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.

Conditions

• Peripheral Arterial Disease

Interventions

DRUG

Ezetimibe

Daily dose of 10 mg of Ezetimibe

DRUG

Niaspan

Daily dose of 1500 mg of Niaspan

DRUG

Statin therapy

Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)

BEHAVIORAL

Standard care

Standard of medical care for PAD

DRUG

Aspirin

Daily dose of 325 mg of aspirin

DRUG

Clopidogrel

Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician

DRUG

Placebo Niaspan

Daily dose of 1500 mg of placebo Niaspan

DRUG

Placebo Ezetimibe

Daily dose of 10 mg of placebo Ezetimibe

PROCEDURE

Percutaneous transluminal angioplasty (PTA)

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Christie M. Ballantyne, MD · Baylor College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-04-30

Primary Completion

2010-12-31

Completion

2010-12-31

Countries

• United States

Study Locations