Clinical trial NCT00687076
Conditions: Peripheral Arterial Disease
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
Sponsor: Baylor College of Medicine
Start date: 2004-04-01; Completion date: 2010-12-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
PAD occurring in the legs is a serious disease that affects about 8 million people in the United States. A person's risk for PAD increases with age but can also be raised by smoking or having diabetes, high blood pressure, high cholesterol, or heart disease. Symptoms of PAD may include leg cramps or pain while walking, foot pain while resting, and skin wounds or ulcers on feet and toes. However, because only about one in three people with PAD knows to seek treatment for these symptoms, many end up with advanced disease that requires significant medical intervention, such as an endovascular or other surgical procedure to open the blocked arteries. While these procedures are helpful in treating people with severe PAD, lifestyle modifications and certain medications are also needed for long-term management of PAD and improved quality of life. An intensive combination of lipid modifying medications may be superior to standard lipid modifying medications in reducing PAD-associated risk factors and improving overall health in people with PAD. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in preventing blockages and re-narrowing of arteries in people with significant PAD who have had an endovascular intervention.

Participation in this study will last a minimum of 2 years and a maximum of 5 years. All participants will first undergo baseline assessments that will include a medical history, vascular and physical exam, electrocardiograph (EKG), magnetic resonance imaging (MRI) scan, 3D ultrasound, blood pressure measurement test in the legs, treadmill walking distance test, urine test, blood draw, and questionnaires. A portion of the blood draw will be used for DNA analysis and genetic testing.

Participants who have not had an endovascular intervention in the 3 months before study entry will undergo a standard of care percutaneous transluminal angioplasty (PTA) procedure. First these, participants will complete a series of clinical review assessments that will include a review of social, vascular, and clinical history. Next, they will undergo the PTA procedure, which will involve the inflation and deflation of a small balloon in the area of 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.

All participants will then be assigned randomly to receive standard care plus an intensive combination of lipid modifying medications (Simvastatin, Plavix, aspirin, Ezetimibe, and Niaspan) or standard lipid modifying medications with placebo (Simvastatin, Plavix, aspirin, placebo Ezetimibe, and placebo Niaspan). Participants will take their assigned medications daily for 24 months. Follow-up visits will occur at Day 10; Week 6; and Months, 6, 12, and 24 after beginning the study medications. During follow-up visits, participants will repeat the baseline assessments and the clinical review assessments from the pre-PTA visit. The Week 6 follow-up visit will include only a blood draw, questionnaires, and the clinical review assessments. Participants will also be contacted by phone to check their status every 2 to 3 months during treatment and every 6 months after treatment for up to 3 years.

Arms: arm 1: Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan. arm 2: Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
Interventions: intervention 1: Ezetimibe intervention 2: Niaspan intervention 3: Statin therapy intervention 4: Standard care intervention 5: Aspirin intervention 6: Clopidogrel intervention 7: Placebo Niaspan intervention 8: Placebo Ezetimibe intervention 9: Percutaneous transluminal angioplasty (PTA)
Intervention descriptions: intervention 1: Daily dose of 10 mg of Ezetimibe intervention 2: Daily dose of 1500 mg of Niaspan intervention 3: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.) intervention 4: Standard of medical care for PAD intervention 5: Daily dose of 325 mg of aspirin intervention 6: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician intervention 7: Daily dose of 1500 mg of placebo Niaspan intervention 8: Daily dose of 10 mg of placebo Ezetimibe intervention 9: 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.

Protocol documents: