At a glance
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Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention ("The ELIMIT Trial")
In Brief
A Phase 4 clinical trial evaluating Ezetimibe, Niaspan, and 7 other interventions for Peripheral Arterial Disease. Completed, enrolled 102 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.