ACAPS
Asymptomatic Carotid Artery Plaque Study
|
Status:
Trial complete. Results published 1995.
Purpose:
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:
Lovastatin
3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor; lowers cholesterol
|
Warfarin
Anticoagulant (Vitamin K antagonist)
|
Year Started:
1988
Year Finished:
1998
Design:
Double-blind, placebo-controlled, factorially designed study of 919 patients.
Inclusion Criteria
Men and women with early carotid atherosclerosis and LDL cholesterol between the 60th and 90th percentiles.
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.
Primary Outcome:
Progression of the mean maximum intimal-medial thickness (IMT) over 12 walls of both carotid arteries.
Results:
Lovastatin treatment was associated with a reduction in progression of mean maximum IMT (p < 0.001). Levels of LDL cholesterol were reduced by 28% (43.5 mg/dl [11.25 mmol/liter]) in the lovastatin group within 6 months (p < 0.0001) and remained stable throughout the follow-up period, whereas these levels remained essentially unchanged in the lovastatin-placebo group.
Source of Information:
Clinicaltrials.gov
|
|
Web Links and Publications:
|
|
This information last updated on: 8/3/2000
|
Trials
Directories