Trial Outcomes & Findings for Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER), Phase I (NCT NCT01004406)

Last Updated: 2019-07-30

Results Overview

The primary effectiveness outcome measure was the change in the total atheroma volume within a ≥ 20 mm long segment of the target coronary artery from baseline to 12 weeks post-PCI. The measurement was done via IVUS-VH at 2 time points (baseline during index PCI and 12-week follow-up).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

59 participants

Primary outcome timeframe

baseline and 12-week follow-up

Results posted on

2019-07-30

Participant Flow

Subject recruitment for Phase I pilot study started on September 6, 2011, and the first participant was randomized on September 8, 2011. The recruitment period stopped in June 2012. For 2 participating sites, Dallas and Oklahoma City randomized 26 and 5 participants, respectively.

There were 59 subjects consented and enrolled into the study before entering catheterization lab to have the PCI procedure, but 28 subjects were not randomized to treatment assignments with the major exclusion reasons as not referred for PCI or not able to comply with study protocol based on the inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	Intensive LDL-lowering Therapy (ILLT) Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Overall Study STARTED	21	10
Overall Study COMPLETED	18	10
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Intensive LDL-lowering Therapy (ILLT) Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER), Phase I

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive LDL-lowering Therapy (ILLT) n=21 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=10 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.	Total n=31 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 6.9 • n=99 Participants	57.6 years STANDARD_DEVIATION 7.7 • n=107 Participants	61.6 years STANDARD_DEVIATION 7.5 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	21 Participants n=99 Participants	10 Participants n=107 Participants	31 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) White	19 Participants n=99 Participants	7 Participants n=107 Participants	26 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	21 Participants n=99 Participants	10 Participants n=107 Participants	31 Participants n=206 Participants
Weight	207.8 pounds STANDARD_DEVIATION 28.9 • n=99 Participants	211.4 pounds STANDARD_DEVIATION 38.8 • n=107 Participants	208.9 pounds STANDARD_DEVIATION 31.8 • n=206 Participants
Height	69.5 inches STANDARD_DEVIATION 2.7 • n=99 Participants	71.0 inches STANDARD_DEVIATION 2.0 • n=107 Participants	70.0 inches STANDARD_DEVIATION 2.6 • n=206 Participants
Heart Rate	76.9 beats/min STANDARD_DEVIATION 11.2 • n=99 Participants	76.3 beats/min STANDARD_DEVIATION 7.2 • n=107 Participants	76.7 beats/min STANDARD_DEVIATION 10.0 • n=206 Participants
Systolic Blood Pressure (SBP)	144.0 mmHg STANDARD_DEVIATION 26.2 • n=99 Participants	150.1 mmHg STANDARD_DEVIATION 23.6 • n=107 Participants	145.9 mmHg STANDARD_DEVIATION 25.2 • n=206 Participants
Diastolic Blood Pressure (DBP)	80.8 mmHg STANDARD_DEVIATION 14.0 • n=99 Participants	85.3 mmHg STANDARD_DEVIATION 14.4 • n=107 Participants	82.3 mmHg STANDARD_DEVIATION 14.1 • n=206 Participants
Smoker Never	6 Participants n=99 Participants	4 Participants n=107 Participants	10 Participants n=206 Participants
Smoker Current	6 Participants n=99 Participants	3 Participants n=107 Participants	9 Participants n=206 Participants
Smoker Former	9 Participants n=99 Participants	3 Participants n=107 Participants	12 Participants n=206 Participants

PRIMARY outcome

Timeframe: baseline and 12-week follow-up

Population: Reported results are based on Intent-to-Treat (ITT) approach.

Outcome measures

Outcome measures
Measure	Intensive LDL-lowering Therapy (ILLT) n=21 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=10 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Change in the Total Atheroma Volume of the Target Coronary Artery From Baseline to 12 Weeks Post-PCI as Assessed Via Intravascular Ultrasound With Virtual Histology (IVUS-VH)	-3.70 mm^3 Standard Deviation 18.52	10.79 mm^3 Standard Deviation 35.23

SECONDARY outcome

Timeframe: baseline and 12-week follow-up

Population: Reported results are based on ITT approach.

The %NC component of atheroma were obtained via IVUS-VH at 2 time points (baseline during index PCI and 12-week follow-up).

Outcome measures

Outcome measures
Measure	Intensive LDL-lowering Therapy (ILLT) n=21 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=10 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Change in % Necrotic Core (NC) Component of Atheroma From Baseline to 12 Weeks Post-PCI as Assessed Via IVUS-VH	0.007 percentage of atheroma component Standard Deviation 0.03	-0.006 percentage of atheroma component Standard Deviation 0.03

SECONDARY outcome

Timeframe: pre-PCI, post-PCI, 4-week follow-up, and 12-week follow-up

Population: Reported results are based on observed data from participants who had secondary outcome measured. This outcome was captured for Dallas site only.

The cell culture assay and quantification of circulating EPC-CFU were performed for patients recruited at the Dallas VA center only. The assay were done at 4 time points (pre-PCI, post-PCI, 4-week follow-up, and 12-week follow-up).

Outcome measures

Outcome measures
Measure	Intensive LDL-lowering Therapy (ILLT) n=16 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=9 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) Per Milliliter of Peripheral Blood Across Time baseline pre-PCI	13.71 colonies/ml Standard Deviation 6.53	13.89 colonies/ml Standard Deviation 4.94
Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) Per Milliliter of Peripheral Blood Across Time baseline post-PCI	15.85 colonies/ml Standard Deviation 6.40	13.33 colonies/ml Standard Deviation 4.29
Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) Per Milliliter of Peripheral Blood Across Time 4-week follow-up	25.39 colonies/ml Standard Deviation 10.31	17.86 colonies/ml Standard Deviation 8.91
Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) Per Milliliter of Peripheral Blood Across Time 12-week follow-up	27.62 colonies/ml Standard Deviation 12.59	21.50 colonies/ml Standard Deviation 9.84

SECONDARY outcome

Timeframe: 6 months

The number of patients who experienced major adverse cardiovascular endpoints (MACE) including death, myocardial infarction, coronary revascularization, and stroke during the follow-up periods.

Outcome measures

Outcome measures
Measure	Intensive LDL-lowering Therapy (ILLT) n=21 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=10 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Major Adverse Cardiovascular Events	1 Participants	0 Participants

Adverse Events

Intensive LDL-lowering Therapy (ILLT)

Serious events: 10 serious events

Other events: 17 other events

Deaths: 0 deaths

Standard Statin Monotherapy (SMT)

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intensive LDL-lowering Therapy (ILLT) n=21 participants at risk Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=10 participants at risk Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
General disorders Chest pain	14.3% 3/21 • Number of events 3 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	20.0% 2/10 • Number of events 2 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Cardiac disorders Coronary artery disease	4.8% 1/21 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	10.0% 1/10 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Cardiac disorders Angina unstable	4.8% 1/21 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/10 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Cardiac disorders Atrial fibrillation	4.8% 1/21 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/10 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Cardiac disorders Ischaemic cardiomyopathy	4.8% 1/21 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/10 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Gastrointestinal disorders Abdominal discomfort	4.8% 1/21 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/10 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
General disorders Catheter site haemorrhage	4.8% 1/21 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/10 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Hepatobiliary disorders Cholecystitis acute	4.8% 1/21 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/10 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Hepatobiliary disorders Gallbladder disorder	4.8% 1/21 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/10 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Immune system disorders Drug hypersensitivity	0.00% 0/21 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	10.0% 1/10 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/21 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	10.0% 1/10 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Vascular disorders Hypertensive crisis	4.8% 1/21 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/10 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Vascular disorders Peripheral vascular disorder	0.00% 0/21 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	10.0% 1/10 • Number of events 1 • Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Adverse Device Effects (UADE) were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.

Other adverse events

Additional Information

Dr. Subhash Banerjee

VA North Texas Health Care System, Dallas, TX and University of Texas Southwestern Medical Center

Phone: 214-857-1608

Email: [email protected], [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place