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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00687076 |
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.
Condition | Intervention | Phase |
Peripheral Arterial Disease |
Drug: Ezetimibe Drug: Niaspan Drug: Statin therapy Behavioral: Standard care Drug: Aspirin Drug: Clopidogrel Drug: Placebo Niaspan Drug: Placebo Ezetimibe Procedure: Percutaneous transluminal angioplasty (PTA) |
Phase IV |
ChemIDplus related topics: | Atorvastatin Atorvastatin calcium Simvastatin Acetylsalicylic acid Ezetimibe Cholest-5-en-3-ol (3beta)- Niacin Niacin hydrochloride Clopidogrel Clopidogrel Bisulfate Lipids |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention ("The ELIMIT Trial") |
Estimated Enrollment: | 120 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.
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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
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.
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2: Active Comparator
Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.
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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.
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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.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christie M. Ballantyne | 713-790-5800 | cmb@bcm.tmc.edu |
Contact: Shawna L. Johnson | 713-798-2301 | shawnaj@bcm.tmc.edu |
United States, Texas | |||||
Baylor College of Medicine | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Contact: Shawna L. Johnson, RN BSN 713-798-4951 ext 2301 shawnaj@bcm.edu | |||||
Contact: Christie M. Ballantyne, MD 713-790-5800 cmb@bcm.edu | |||||
Principal Investigator: Christie M. Ballantyne, MD | |||||
Sub-Investigator: Peter Lin, MD | |||||
Sub-Investigator: Joel Morrisett, PhD | |||||
Sub-Investigator: Johnny Chen, MD, PhD | |||||
Sub-Investigator: ViJay Nambi, MD | |||||
Sub-Investigator: Tam Huynh, MD | |||||
Sub-Investigator: Jing-Fei Dong | |||||
Sub-Investigator: Panagiotis Kougias, MD | |||||
Sub-Investigator: Ron Hoogeveen, PhD |
Principal Investigator: | Christie M. Ballantyne, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Christie M. Ballantybe MD, Principal Investigator ) |
Study ID Numbers: | 1400, R01 HL075824 |
First Received: | May 28, 2008 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00687076 |
Health Authority: | United States: Food and Drug Administration |
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