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

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Abbott; Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.; National Heart, Lung, and Blood Institute (NHLBI); Pfizer; Upsher-Smith Laboratories
• Treatments: Atorvastatin; Atorvastatin Calcium; Colesevelam Hydrochloride; Niacin; Niacinamide; Nicotinic Acids

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