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

This study is currently recruiting participants.
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

July 11, 2008
December 10, 2013
June 2001
December 2015   (final data collection date for primary outcome measure)
Changes in carotid plaque composition, as assessed by MRI [ Time Frame: Measured at Years 1, 2, and 3 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00715273 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication
Carotid Plaque Composition by Magnetic Resonance Imaging During Lipid Lowering Therapy

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Coronary Artery Disease
  • Carotid Artery Diseases
  • Atherosclerosis
  • 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
  • Drug: Placebo Niacin
    Placebo niacin each day
  • Drug: Placebo Colesevelam
    Placebo colesevelam each day
  • 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.
    Interventions:
    • Drug: Atorvastatin
    • Drug: Placebo Niacin
    • Drug: Placebo Colesevelam
  • 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.
    Interventions:
    • Drug: Atorvastatin
    • Drug: Niacin
    • Drug: Placebo Colesevelam
  • 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
    Interventions:
    • Drug: Atorvastatin
    • Drug: Niacin
    • Drug: Colesevelam

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
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
 
NCT00715273
587, R01HL063895-05A1
Yes
Xue-Qiao Zhao, University of Washington
University of Washington
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pfizer
  • Abbott
  • Daiichi Sankyo Inc.
  • Upsher-Smith Laboratories
Principal Investigator: Xue-Qiao Zhao, MD University of Washington
University of Washington
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP