102
Participants
Start Date
April 30, 2004
Primary Completion Date
December 31, 2010
Study Completion Date
December 31, 2010
Ezetimibe
Daily dose of 10 mg of Ezetimibe
Niaspan
Daily dose of 1500 mg of Niaspan
Statin therapy
Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)
Standard care
Standard of medical care for PAD
Aspirin
Daily dose of 325 mg of aspirin
Clopidogrel
Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician
Placebo Niaspan
Daily dose of 1500 mg of placebo Niaspan
Placebo Ezetimibe
Daily dose of 10 mg of placebo Ezetimibe
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.
Baylor College of Medicine, Houston
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Baylor College of Medicine
OTHER