Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00715273
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00715273
Recruitment Status : Active, not recruiting
First Posted : July 15, 2008
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Pfizer
Abbott
Daiichi Sankyo, Inc.
Upsher-Smith Laboratories
Information provided by (Responsible Party):
Xue-Qiao Zhao, University of Washington

Tracking Information
First Submitted Date  ICMJE July 11, 2008
First Posted Date  ICMJE July 15, 2008
Last Update Posted Date February 28, 2019
Study Start Date  ICMJE June 2001
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2017)
Changes in carotid plaque composition, as assessed by MRI [ Time Frame: Measured at Years 1, 2, and 3 ]
The primary endpoint of this study is carotid plaque lipid composition identified by MRI. The determination of plaque lipid content for each carotid artery will be performed using the automated interactive system. These measurements will be performed from the MRI scans at four time points blinded to time sequence of MRI examinations, patient treatment, lipid levels and clinical course.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2008)
Changes in carotid plaque composition, as assessed by MRI [ Time Frame: Measured at Years 1, 2, and 3 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2017)
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 ]
Any cardiovascular events such as death from any cause, nonfatal myocardial infarction, stroke, and revascularization procedures (PCI or CABG) due to unstable ischemia will be recorded and verified.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication
Official Title  ICMJE Carotid Plaque Composition by Magnetic Resonance Imaging During Lipid Lowering Therapy
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Coronary Artery Disease
  • Carotid Artery Diseases
  • Atherosclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 1, 2015)
217
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2008)
180
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00715273
Other Study ID Numbers  ICMJE STUDY00001165
R01HL063895-05A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xue-Qiao Zhao, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pfizer
  • Abbott
  • Daiichi Sankyo, Inc.
  • Upsher-Smith Laboratories
Investigators  ICMJE
Principal Investigator: Xue-Qiao Zhao, MD University of Washington
PRS Account University of Washington
Verification Date February 2019

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