Phase 4
N=217
Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication
Coronary Artery Disease · Carotid Artery Diseases · Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00715273 ↗Enrolled (actual)
217
Serious AEs
30.4%
Results posted
Jun 2022
Primary outcome: Primary: Annualized LRNC Volume Change in Carotid Plaque Composition, as Assessed by MRI — -4.6; -15.1; -9.4 mm^3/year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atorvastatin (Drug); Niacin (Drug); Colesevelam (Drug); Placebo Niacin (Drug); Placebo Colesevelam (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized LRNC Volume Change in Carotid Plaque Composition, as Assessed by MRI |
-4.6; -15.1; -9.4 | — |
| PRIMARY Annualized LRNC and Wall Volume Changes in Carotid Plaque Composition, as Assessed by MRI |
-1.6; -3.6; -2.8; -0.6; -1.4; -1.2 | — |
| SECONDARY Composite of Cardiovascular Endpoints: Number of Participants With Cardiovascular Disease Death, Non-fatal Heart Attack, Stroke, and Worsening Ischemia Requiring Medical Interventions |
6; 6; 7; 7; 11; 9 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00715273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.