Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
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.
Timeline
- Start
- 2004-04
- Primary completion
- 2010-12
- Completion
- 2010-12
Outcome
Missed primary endpoint
paper SFA wall, lumen, and total vessel volumes increased non-significantly for both groups between baseline and 24-months. PMID 24267254 ↗
paper No significant differences were observed between mono-therapy using simvastatin and triple-therapy with simvastatin, extended-release niacin, and ezetimibe PMID 24267254 ↗
Publications
- Background Lumsden AB, Rice TW, Chen C, Zhou W, Lin PH, Bray P, Morrisett J, Nambi V, Ballantyne C. Peripheral arterial occlusive disease: magnetic resonance imaging and the role of aggressive medical management. World J Surg. 2007 Apr;31(4):695-704. doi: 10.1007/s00268-006-0732-y.
- Results Brunner G, Yang EY, Kumar A, Sun W, Virani SS, Negi SI, Murray T, Lin PH, Hoogeveen RC, Chen C, Dong JF, Kougias P, Taylor A, Lumsden AB, Nambi V, Ballantyne CM, Morrisett JD. The Effect of Lipid Modification on Peripheral Artery Disease after Endovascular Intervention Trial (ELIMIT). Atherosclerosis. 2013 Dec;231(2):371-7. doi: 10.1016/j.atherosclerosis.2013.09.034. Epub 2013 Oct 16.
- Results Saunders J, Nambi V, Kimball KT, Virani SS, Morrisett JD, Lumsden AB, Ballantyne CM, Dong JF; ELIMIT Investigators. Variability and persistence of aspirin response in lower extremity peripheral arterial disease patients. J Vasc Surg. 2011 Mar;53(3):668-75. doi: 10.1016/j.jvs.2010.08.029. Epub 2011 Jan 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezetimibe | Unknown | 10 mg | — |
| Subject | Niacin | Small molecule | 1500 mg | — |
| Background | Aspirin | Small molecule | 325 mg | — |
| Background | Atorvastatin | Small molecule | — | — |
| Background | Clopidogrel | Small molecule | 75 mg | — |
| Background | Simvastatin | Small molecule | 40 mg | — |