Phase 4
N=102
Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT00687076 ↗Enrolled (actual)
102
Serious AEs
11.6%
Results posted
Aug 2014
Primary outcome: Primary: 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; 60.5 mm^3, at 24-months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ezetimibe (Drug); Niaspan (Drug); Statin therapy (Drug); Standard care (Behavioral); Aspirin (Drug); Clopidogrel (Drug); Placebo Niaspan (Drug); Placebo Ezetimibe (Drug); Percutaneous transluminal angioplasty (PTA) (Procedure)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 60.5 | — |
| SECONDARY Change in Total Cholesterol (mg/dl) From Baseline to Month 12 |
-30.0; -7.5 | — |
Summary
Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Early identification of PAD and treatment with lifestyle changes or medications can help to keep legs healthy and lower risk for heart attack and stroke, but endovascular or surgical procedures may be necessary for people with severe PAD. Even after endovascular intervention, PAD symptoms must be continually monitored to prevent the development and progression of blockages in the arteries. The best approach for monitoring symptoms is still undetermined. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in treating people with significant PAD who have had an endovascular intervention.
Eligibility Criteria
Inclusion Criteria
- Symptoms consistent with calf claudication and described as life style limiting
- Objective evidence of peripheral artery disease (PAD): Ankle brachial index less than 0.9 OR other hemodynamic or imaging modalities confirming significant PAD
- Baseline imaging reveals superficial femoral artery (SFA) disease starting at least 5 cm from the origin of the SFA
- Agrees to be available for follow-up and is able to participate in all study testing procedures
- Weight and/or body characteristics that will allow testing with MRI
- No known contraindication to lipid lowering agents
- Serum creatinine level less than 2.5 mg/dL
- Scheduled to undergo or has already undergone an endovascular intervention of a de novo lesion in the SFA with an anticipated result that would satisfy hemodynamic stability OR is medically managed and does not require an intervention at this time
- Compressible arteries (if not, has toe brachial index [TBI] less than 0.7)
- Has/had an A, B, C lesion amendable to a catheter based therapy (prior bypass is acceptable)
Exclusion Criteria
- Non-atherosclerotic disease that is responsible for claudication
- Unstable cardiac disease (e.g., unstable angina, heart attack within the 30 days before study entry, uncontrolled coronary heart failure, poorly controlled hypertension [systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg], ventricular arrhythmias)
- Pancreatitis
- Documented hypercoagulable state
- Clinically severe diabetic neuropathy
- Rest pain, gangrene, or tissue loss
- Active peptic ulcer disease or a recent gastrointestinal bleed that would prohibit the use of an anti-platelet (aspirin/Plavix)
- Untreated or unsuccessfully controlled psychiatric disease
- Chronic hepatic disease determined by aspartate transaminase (AST) and/or alanine transaminase (ALT) more than 3 times upper limit of normal (ULN) and/or total bilirubin more than 2 times ULN
- Creatine phosphokinase (CPK) more than 3 times ULN (may be repeated once before patient is excluded)
- Active gout symptoms or a uric acid level greater than 1.3 times ULN
- Untreated hypothyroidism
- Allergy to Plavix, nickel, titanium, niacin, Ezetimibe, statins, or their derivatives
- Participated in another interventional study within the 30 days before study entry
- Scheduled to undergo planned synchronous bilateral percutaneous transluminal angioplasty (PTA) procedures
- Requires an above the ankle amputation
- Scheduled to undergo elective surgery within 30 days after the PTA procedure
- Has an implanted pacemaker, defibrillator, neural stimulator, brain clip, insulin pump, cochlear implant, or any other predetermined radiographic finding that would exclude MRI testing
- Has claustrophobia that would prevent MRI testing
- Recent drug or alcohol abuse history (less than 6 months before study entry) or is currently using or abusing excessive alcohol or drugs (excessive alcohol will be defined as greater than 14 drinks per week)
- Past recipient of a cardiac, kidney, liver, lung, or other organ transplant (skin grafts are acceptable)
Data sourced from ClinicalTrials.gov (NCT00687076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.