Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: Ezetimibe; Niaspan; Statin therapy; Standard care; Aspirin; Clopidogrel; Placebo Niaspan; Placebo Ezetimibe; Percutaneous transluminal angioplasty (PTA)
Intervention description: Daily dose of 10 mg of Ezetimibe; Daily dose of 1500 mg of Niaspan; Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.); Standard of medical care for PAD; Daily dose of 325 mg of aspirin; Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician; Daily dose of 1500 mg of placebo Niaspan; Daily dose of 10 mg of placebo Ezetimibe; Participants who have not had an endovascular intervention in the 3 months before study entry will undergo PTA to mechanically open the artery blockages. This procedure will involve the inflation and deflation of a small balloon to open the blocked artery. Additionally, participants may have a metal mesh tube called a stent placed in the blocked area if deemed necessary by their physicians.
Intervention MeSH terms: Aspirin; Niacin; Nicotinic Acids; Clopidogrel; Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Endovascular Intervention; MRI; Ultrasound; Cholesterol Medications; High Cholesterol; Peripheral Arterial disease; Claudication; Leg Pain; Niaspan; Extended Release Niacin; Zetia; Ezetimibe; Simvastatin; Zocor; Atorvastatin; Lipitor

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)