Asymptomatic Carotid Artery Plaque Study "ACAPS"

Completed

Phase N/A Results

Trial Description

This study tested the effect of the HMG-CoA reductase inhibitor, lovastatin, on early-stage carotid atherosclerosis (as detected by B-mode ultrasonography) in 919 asymptomatic men and women, 40-79 years of age with moderately elevated LDL cholesterol.

Interventions

  • Warfarin (Coumadin┬«)Drug
    Intervention Desc: Anticoagulant (Vitamin K antagonist)
  • Lovastatin (Mevacor)Drug
    Other Names: Mevacor
    Intervention Desc: 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor; lowers cholesterol

Trial Design

Double-blind, placebo-controlled, factorially designed study of 919 patients.

Patient Involvement

Participants received lovastatin (20-40 mg/day) or lovastatin-placebo and warfarin (1 mg/day), or warfarin-placebo over a 3-year period.

Outcomes

Type Measure Time Frame Safety Issue
Primary Progression of the mean maximum intimal-medial thickness (IMT) over 12 walls of both carotid arteries.