Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication
NCT00715273
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Los Angeles, California
- Boise, Idaho
- Seattle, Washington
- Yakima, Washington
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:
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 |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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 | Unknown status | |||
Actual Enrollment ICMJE | 217 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
Responsible Party | Xue-Qiao Zhao, University of Washington | |||
Study Sponsor ICMJE | University of Washington | |||
Collaborators ICMJE |
| |||
Investigators ICMJE |
| |||
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 |