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

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.

Conditions

• Coronary Artery Disease
• Carotid Artery Diseases
• Atherosclerosis

Interventions

DRUG

Atorvastatin

10 to 80 mg of atorvastatin each day

DRUG

Niacin

2000 mg of niacin each day

DRUG

Colesevelam

3.8 g of colesevelam each day

DRUG

Placebo Niacin

Placebo niacin each day

DRUG

Placebo Colesevelam

Placebo colesevelam each day

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Pfizer

  collaborator INDUSTRY

• Abbott

  collaborator INDUSTRY

• Daiichi Sankyo

  collaborator INDUSTRY

• Upsher-Smith Laboratories

  collaborator INDUSTRY

• University of Washington

  lead OTHER

Principal Investigators

• Xue-Qiao Zhao, MD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-05-01

Primary Completion

2018-12-12

Completion

2019-03-01

FDA Drug

Yes

Countries

• United States

Study Locations