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

NCT00715273

CompletedPhase 4

Sponsor: University of Washington

Conditions: Coronary Artery Disease, Carotid Artery Diseases, Atherosclerosis

Interventions: Atorvastatin, Niacin, Colesevelam, Placebo Niacin, Placebo Colesevelam

Countries: United States

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 overview

Sex: ALL

Age: 21 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (4)
  • Los Angeles, California, United States
  • Boise, Idaho, United States
  • Seattle, Washington, United States
  • Yakima, Washington, United States