Status:
COMPLETED
Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief 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...
Detailed Description
PAD occurring in the legs is a serious disease that affects about 8 million people in the United States. A person's risk for PAD increases with age but can also be raised by smoking or having diabetes...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00687076
Start Date
April 1 2004
End Date
December 1 2010
Last Update
February 6 2020
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030