Using Magnetic Resonance Imaging to Evaluate Carotid Artery Plaque Composition in People Receiving Cholesterol-Lowering Medications (The CPC Study)
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Purpose
Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls of arteries. This study will examine the effectiveness of a combination of cholesterol-lowering medications at decreasing the fat content of atherosclerotic deposits in people who have coronary artery disease or carotid artery disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Carotid Artery Diseases Atherosclerosis |
Drug: Atorvastatin Drug: Niacin Drug: Colesevelam Drug: Placebo Niacin Drug: Placebo Colesevelam |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Carotid Plaque Composition by Magnetic Resonance Imaging During Lipid Lowering Therapy |
- Changes in carotid plaque composition, as assessed by MRI [ Time Frame: Measured at Years 1, 2, and 3 ] [ Designated as safety issue: Yes ]
- Composite of cardiovascular disease death, non-fatal heart attack, stroke, and worsening ischemia requiring medical interventions [ Time Frame: Measured at Years 3, 4, and 5 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 180 |
| Study Start Date: | June 2001 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will receive atorvastatin, placebo niacin, and placebo colesevelam.
|
Drug: Atorvastatin
10 to 80 mg of atorvastatin each day
Other Name: Lipitor
Drug: Placebo Niacin
Placebo niacin each day
Drug: Placebo Colesevelam
Placebo colesevelam each day
|
|
Experimental: 2
Participants will receive atorvastatin, niacin, and placebo colesevelam.
|
Drug: Atorvastatin
10 to 80 mg of atorvastatin each day
Other Name: Lipitor
Drug: Niacin
2000 mg of niacin each day
Other Names:
Drug: Placebo Colesevelam
Placebo colesevelam each day
|
|
Experimental: 3
Participants will receive atorvastatin, niacin, and colesevelam.
|
Drug: Atorvastatin
10 to 80 mg of atorvastatin each day
Other Name: Lipitor
Drug: Niacin
2000 mg of niacin each day
Other Names:
Drug: Colesevelam
3.8 g of colesevelam each day
Other Name: WelChol
|
Detailed Description:
Atherosclerosis is a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries; these deposits are known as plaque. People with atherosclerosis are at risk of developing coronary artery disease, in which plaque build-up occurs in the arteries that supply blood to the heart, and carotid artery disease, in which plaque build-up occurs in the arteries that deliver blood through the neck to the brain. These conditions can lead to blood clots, heart attack, and stroke. Research has shown that people who have more fat content in atherosclerotic plaque may have a higher risk of experiencing a heart attack or stroke. Treatments for atherosclerosis include lifestyle changes, medicines, and medical procedures or surgery. There are several medications that can aid people in controlling their cholesterol levels, including atorvastatin, a medication that inhibits the production of cholesterol; niacin, a B-complex vitamin that can reduce cholesterol levels in combination with dietary changes; and colesevelam, a medication that inhibits fat absorption. Using magnetic resonance imaging (MRI), this study will evaluate whether these medications, alone or in combination, can decrease the fat content of atherosclerotic plaques within the carotid arteries of people with coronary artery disease and carotid artery disease.
This study will enroll people with coronary artery disease or carotid artery disease. Participants will be randomly assigned to one of the following 40-month treatment groups:
- Group 1 participants will receive atorvastatin, placebo niacin, and placebo colesevelam each day.
- Group 2 participants will receive atorvastatin, niacin, and placebo colesevelam each day.
- Group 3 participants will receive atorvastatin, niacin, and colesevelam each day.
At a baseline study visit, participants will undergo a blood collection and will receive dietary counseling that will focus on lowering cholesterol levels. They will also undergo an MRI scan of their carotid arteries. For the next 4 months, participants will attend monthly study visits for repeat blood collection and dietary counseling; for the subsequent 36 months, participants will attend study visits every other month. Repeat carotid artery MRI scans will occur at Months 12, 24, and 36. At three different times during the study, researchers will ask participants to record their food consumption for 3 consecutive days.
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinically established coronary artery disease or carotid artery disease with greater than 15% stenosis by ultrasound
- Family history of cardiovascular disease
- Apolipoprotein B level greater than or equal to 120 mg/dL (LDL level should be between 100 and 190 mg/dL without medication)
- Has been undergoing lipid therapy for no more than 12 months before study entry
- Medically stable
- Medically able to undergo MRI procedure
Exclusion Criteria:
- Uses pacemaker or has metallic implants
- Has immediate plans for carotid endarterectomy
- History of alcohol or drug abuse
- Active liver disease or liver dysfunction, defined by elevations in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal
- Serum creatine kinase (CK) level greater than 3 times the upper limit of normal before study entry
- Serum creatinine level greater than 2.5 times the upper limit of normal
- Diabetes, with a fasting glucose level greater than 150 mg/dL or hemoglobin A1c (HbA1c) level greater than 8% before study entry
- Uncontrolled high blood pressure, defined as average resting systolic blood pressure greater than 200 mm Hg or average resting diastolic blood pressure greater than 95 mm Hg
Contacts and Locations| Contact: Xue-Qiao Zhao, MD | 206-744-8305 | xueqiao@u.washington.edu |
| Contact: Barbara Twaddell, RN | 206-744-9203 | barbt@u.washington.edu |
| United States, California | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90089 | |
| Contact: Andrea Contreras, BS 323-226-7263 a.contreras@usc.edu | |
| Contact: Barbara Twaddell, RN 866-866-0175 barbt@u.washington.edu | |
| Sub-Investigator: Patrick Colletti, MD | |
| United States, Idaho | |
| St. Luke's Idaho Cardiology | Completed |
| Boise, Idaho, United States, 83712 | |
| United States, Washington | |
| University of Washington Coronary Atherosclerosis Research Lab | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Barbara Twaddell, RN 206-744-9203 barbt@u.washington.edu | |
| Contact: Xue-Qiao Zhao, MD 206-744-8305 xueqiao@u.washington.edu | |
| Principal Investigator: Xue-Qiao Zhao, MD | |
| Sub-Investigator: Thomas Hatsukami, MD | |
| Yakima Heart Center | Recruiting |
| Yakima, Washington, United States, 98902 | |
| Contact: Barbara Twaddell, RN 866-866-0175 barbt@u.washington.edu | |
| Contact: Xue-Qiao Zhao, MD 866-866-0175 xueqiao@u.washington.edu | |
| Sub-Investigator: Duane A. Monick, MD | |
| Principal Investigator: | Xue-Qiao Zhao, MD | University of Washington |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Xue-Qiao Zhao, Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00715273 History of Changes |
| Other Study ID Numbers: | 587, R01HL063895-05A1, 2 R01 HL063895-05A1 |
| Study First Received: | July 11, 2008 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Washington:
|
Magnetic Resonance Imaging Atherosclerotic Plaque Lipid Lowering Therapy |
Additional relevant MeSH terms:
|
Niacin Nicotinic Acids Niacinamide Atherosclerosis Carotid Artery Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Carotid Stenosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Heart Diseases Atorvastatin Colesevelam Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamin B Complex Vitamins |
ClinicalTrials.gov processed this record on May 21, 2013