Asymptomatic Carotid Artery Plaque Study (ACAPS)

May 12, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To determine whether warfarin or lovastatin alone or in combination retarded the progression of atherosclerotic plaques in the carotid arteries of high risk individuals with asymptomatic carotid stenosis. Also, to determine if a full scale trial was feasible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

At the present time, atherosclerosis of the major extracranial arteries to the brain is considered the cause of most strokes. Early intervention and stroke prevention utilized anti-coagulants such as coumadin and heparin. Results were largely equivocal due to the diverse nature of the underlying pathogenesis and due to problems that offset potential benefit. Emphasis gradually switched to aspirin and to other platelet anti-aggregant drugs because of mounting evidence that micro-emboli were a major element in transient ischemic attacks. Several studies have examined the potential benefit of aspirin in stroke prevention. The exact dose of aspirin that was maximally beneficial with minimal side effects was not completely established. There was evidence that low dose aspirin was as effective as higher doses. The American College of Chest Physicians (ACCP) made recommendations that if aspirin were issued as a primary anti-thrombotic agent, the dose should be 325 mg daily, except in patients with cerebrovascular disease in whom the lowest beneficial dose appeared to be one gram per day. The ACCP also pointed out that the risk of bleeding was substantially greater in patients with ischemic cerebrovascular disease and venous thromboembolism than in other high risk groups requiring anticoagulation. It advised that anticoagulant therapy was not needed, but that aspirin might be given at 325 mg per day.

Lovastatin is a fungal metabolite that inhibits 3-hydroxy, 3-methyl glutaryl coenzyme A reductase, the rate-limiting enzyme of cholesterol biosynthesis in human cells including the liver. Inhibition of this pathway causes the cells to increase their low density lipoprotein receptor numbers to compensate, causing a reduction in circulating low density lipoprotein levels with a consequent drop in circulating plasma cholesterol levels. The drug also raises high density lipoprotein levels significantly. A favorable outcome of the trial will have major public health implications for the prevention and control of atherosclerosis and its complications.

DESIGN NARRATIVE:

Randomized, double-blind, factorial design. In this multicenter study, patients were assigned to one of four drug combination groups: active lovastatin/active warfarin, active lovastatin/warfarin placebo, lovastatin placebo/active warfarin, and lovastatin placebo/warfarin placebo. Daily aspirin was recommended for everyone. Ultrasound was performed for screening, at baseline and semiannually thereafter. Lipid profiles were obtained at screening, at baseline, monthly for the first three months, at six months, and annually thereafter, with beta quantification at baseline. Recruitment began in the tenth month of the trial and continued for one year, ending in September 1990. Treatment continued through the 51st month. Average treatment period was 2.7 years. Subjects were offered a dietary regimen for three months prior to receiving any drug therapy. Only those individuals whose lipid levels did not fall below a certain point continued in dietary intervention. The primary outcome measure was the three year change in mean maximum intimal-medial thickness (IMT) in twelve walls of the carotid arteries. Secondary outcomes included change in single maximum IMT and incidence of major cardiovascular events.

In 1995, an R03 was awarded to Mark Espeland to extend analyses of the carotid B-mode ultrasound data through August, 1998.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Men and women with early carotid atherosclerosis and moderately elevated LDL cholesterol between the 60th and 90th percentiles.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Mark Espeland, Bowman Gray School of Medicine
  • Curt Furberg, Bowman Gray School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1988

Study Completion (Actual)

August 1, 1998

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

April 1, 2000

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58
  • R01HL038194 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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