Trial Outcomes & Findings for Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study) (NCT NCT00687076)
NCT ID: NCT00687076
Last Updated: 2020-02-06
Results Overview
The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed. Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. The multilevel models (primary endpoint) used all available imaging data (n=91), including patients who only completed baseline imaging (n=20) or completed at least 2 imaging visits other than baseline (n=4).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
Measured at baseline and 24 Months
Results posted on
2020-02-06
Participant Flow
Participant milestones
| Measure |
Triple Therapy
Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
Mono Therapy
Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
32
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
Baseline characteristics by cohort
| Measure |
Triple Therapy
n=47 Participants
Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
Mono Therapy
n=48 Participants
Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
63.9 years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
63.0 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 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
|
13 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
76 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
|
47 participants
n=99 Participants
|
48 participants
n=107 Participants
|
95 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and 24 MonthsPopulation: Multilevel models were used to describe changes over time in the MRI outcome variables and to compare the drug therapy groups. The advantage of multilevel models is the capability to use data with missing or irregularly timed observations, due to death or loss to follow-up, on the outcome variable.
The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed. Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. The multilevel models (primary endpoint) used all available imaging data (n=91), including patients who only completed baseline imaging (n=20) or completed at least 2 imaging visits other than baseline (n=4).
Outcome measures
| Measure |
Triple Therapy
n=45 Participants
Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
Mono Therapy
n=46 Participants
Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
|---|---|---|
|
Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis
|
58.1 mm^3, at 24-months
Standard Error 5.5
|
60.5 mm^3, at 24-months
Standard Error 5.1
|
SECONDARY outcome
Timeframe: Measured at baseline and 12 monthsPopulation: All values are medians and interquartile range (IQR). P-values were calculated with the KruskaleWallis rank test.
Lipids: Total cholesterol (mg/dl); Lipid Data at 12-Months (change from baseline) \[mg/dl\].
Outcome measures
| Measure |
Triple Therapy
n=47 Participants
Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
Mono Therapy
n=48 Participants
Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
|---|---|---|
|
Change in Total Cholesterol (mg/dl) From Baseline to Month 12
|
-30.0 mg/dl
Interval -63.0 to -1.0
|
-7.5 mg/dl
Interval -30.5 to 8.0
|
Adverse Events
Triple Therapy
Serious events: 7 serious events
Other events: 10 other events
Deaths: 4 deaths
Mono Therapy
Serious events: 4 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Triple Therapy
n=47 participants at risk
Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
Mono Therapy
n=48 participants at risk
Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
6.4%
3/47 • Major adverse events were reported to and assessed by the Data and Safety Monitoring Board (DSMB).
|
2.1%
1/48 • Major adverse events were reported to and assessed by the Data and Safety Monitoring Board (DSMB).
|
|
Cardiac disorders
Major stroke
|
4.3%
2/47 • Major adverse events were reported to and assessed by the Data and Safety Monitoring Board (DSMB).
|
4.2%
2/48 • Major adverse events were reported to and assessed by the Data and Safety Monitoring Board (DSMB).
|
|
Cardiac disorders
Coronary revascularization
|
4.3%
2/47 • Major adverse events were reported to and assessed by the Data and Safety Monitoring Board (DSMB).
|
2.1%
1/48 • Major adverse events were reported to and assessed by the Data and Safety Monitoring Board (DSMB).
|
Other adverse events
| Measure |
Triple Therapy
n=47 participants at risk
Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
Ezetimibe: Daily dose of 10 mg of Ezetimibe
Niaspan: Daily dose of 1500 mg of Niaspan
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
Mono Therapy
n=48 participants at risk
Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care: Standard of medical care for PAD
Aspirin: Daily dose of 325 mg of aspirin
Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe
Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA.
|
|---|---|---|
|
Endocrine disorders
Blood Glucose Adverse Events
|
21.3%
10/47 • Major adverse events were reported to and assessed by the Data and Safety Monitoring Board (DSMB).
|
16.7%
8/48 • Major adverse events were reported to and assessed by the Data and Safety Monitoring Board (DSMB).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place