Trial Outcomes & Findings for Impact of LDL-cholesterol Lowering on Platelet Activation (NCT NCT03331666)
NCT ID: NCT03331666
Last Updated: 2021-04-01
Results Overview
ADP- or arachidonic acid-stimulated platelet aggregation as assessed by the commercially-available VerifyNow P2Y12 (VerifyNow PRUTest) will be performed. Unit: PRU
TERMINATED
PHASE4
4 participants
Day 7, Day 14, Day 21, Day 28, Day 84
2021-04-01
Participant Flow
Participant milestones
| Measure |
Evolocumab
Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 14 until Day 196.
Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
|
Placebo
Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 28 until Day 196.
Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Evolocumab
Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 14 until Day 196.
Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
|
Placebo
Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 28 until Day 196.
Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
|
|---|---|---|
|
Overall Study
Due to Covid-19 pandemic, the trial was prematurely terminated
|
2
|
2
|
Baseline Characteristics
Impact of LDL-cholesterol Lowering on Platelet Activation
Baseline characteristics by cohort
| Measure |
Evolocumab
n=2 Participants
Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 14 until Day 196.
Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
|
Placebo
n=2 Participants
Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 28 until Day 196.
Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=39 Participants
|
2 participants
n=41 Participants
|
4 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28, Day 84Population: Adult male and female subjects who have a clinical diagnosis of familial hypercholesterolemia and referred for treatment with PCSK9 inhibitor, with LDL cholesterol levels ≥70 mg/dl on baseline treatment with statins and/or ezetimibe or intolerant to statin and/or ezetimibe. Of the four participants reported in this study, one participant per arm had ADP assessed by PRU Test (evolocumab and placebo arms) and one participant per arm had ADP assessed by Aspirin assay (evolocumab and placebo arms).
ADP- or arachidonic acid-stimulated platelet aggregation as assessed by the commercially-available VerifyNow P2Y12 (VerifyNow PRUTest) will be performed. Unit: PRU
Outcome measures
| Measure |
Evolocumab
n=1 Participants
Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 14 until Day 196.
Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
|
Placebo
n=1 Participants
Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 28 until Day 196.
Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
|
|---|---|---|
|
Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (P2Y12 Reaction Units (PRU))
P2Y12 Test, Day 7
|
266 PRU
|
216 PRU
|
|
Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (P2Y12 Reaction Units (PRU))
P2Y12 Test, Day 14
|
268 PRU
|
226 PRU
|
|
Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (P2Y12 Reaction Units (PRU))
P2Y12 test, Day 21
|
268 PRU
|
233 PRU
|
|
Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (P2Y12 Reaction Units (PRU))
P2Y12 Test, Day 28
|
276 PRU
|
225 PRU
|
|
Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (P2Y12 Reaction Units (PRU))
P2Y12 Test, Day 84
|
256 PRU
|
267 PRU
|
PRIMARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28, Day 84Population: Adult male and female subjects who have a clinical diagnosis of familial hypercholesterolemia and referred for treatment with PCSK9 inhibitor, with LDL cholesterol levels ≥70 mg/dl on baseline treatment with statins and/or ezetimibe or intolerant to statin and/or ezetimibe. Of the four participants reported in this study, one participant per arm had ADP assessed by PRU Test (evolocumab and placebo arms) and one participant per arm had ADP assessed by Aspirin assay (evolocumab and placebo arms).
ADP- or arachidonic acid-stimulated platelet aggregation as assessed by the commercially-available VerifyNow Aspirin assay (Accriva Diagnostics) will be performed. Unit: Aspirin Reaction Unit (ARU)
Outcome measures
| Measure |
Evolocumab
n=1 Participants
Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 14 until Day 196.
Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
|
Placebo
n=1 Participants
Subjects will start with placebo and will receive Evolocumab 140 mg every 14 days starting Day 28 until Day 196.
Evolocumab: 140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
|
|---|---|---|
|
Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (Aspirin Reaction Unit (ARU))
Aspirin Test, Day 7
|
521 ARU
|
432 ARU
|
|
Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (Aspirin Reaction Unit (ARU))
Aspirin Test Day 14
|
608 ARU
|
401 ARU
|
|
Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (Aspirin Reaction Unit (ARU))
Aspirin Test, Day 21
|
533 ARU
|
490 ARU
|
|
Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (Aspirin Reaction Unit (ARU))
Aspirin Test, Day 28
|
530 ARU
|
512 ARU
|
|
Adenosine Di-phosphate (ADP) Induced, P2Y12 Dependent and Arachidonic Acid Induced Platelet Activation (Aspirin Reaction Unit (ARU))
Aspirin Test, Day 84
|
406 ARU
|
386 ARU
|
Adverse Events
Evolocumab
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place