Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication (CPC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Collaborators:
Pfizer
Abbott
Daiichi Sankyo Inc.
Upsher-Smith Laboratories
Information provided by (Responsible Party):
Xue-Qiao Zhao, University of Washington
ClinicalTrials.gov Identifier:
NCT00715273
First received: July 11, 2008
Last updated: December 10, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Changes in carotid plaque composition, as assessed by MRI [ Time Frame: Measured at Years 1, 2, and 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 - single therapy group
Participants will receive atorvastatin, placebo niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the single therapy group.
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 - double therapy group
Participants will receive atorvastatin, niacin, and placebo colesevelam. The treatment target for LDL-C will be ≤80 mg/dl for the double therapy group.
Drug: Atorvastatin
10 to 80 mg of atorvastatin each day
Other Name: Lipitor
Drug: Niacin
2000 mg of niacin each day
Other Names:
  • Niaspan
  • Slo-niacin
Drug: Placebo Colesevelam
Placebo colesevelam each day
Experimental: 3 - triple therapy group
Participants will receive atorvastatin, niacin, and colesevelam. The treatment target for LDL-C will be ≤60 mg/dl for the triple therapy group
Drug: Atorvastatin
10 to 80 mg of atorvastatin each day
Other Name: Lipitor
Drug: Niacin
2000 mg of niacin each day
Other Names:
  • Niaspan
  • Slo-niacin
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715273

Contacts
Contact: Xue-Qiao Zhao, MD 206-744-8305 xueqiao@u.washington.edu
Contact: Barbara Twaddell, RN 206-744-9203 barbt@u.washington.edu

Locations
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         
Sponsors and Collaborators
University of Washington
Pfizer
Abbott
Daiichi Sankyo Inc.
Upsher-Smith Laboratories
Investigators
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
Study First Received: July 11, 2008
Last Updated: December 10, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Magnetic Resonance Imaging
Atherosclerotic Plaque
Lipid Lowering Therapy

Additional relevant MeSH terms:
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
Niacin
Atorvastatin
Colesevelam
Nicotinic Acids
Niacinamide
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 July 23, 2014