Rationale and design for the Asymptomatic Carotid Artery Plaque Study (ACAPS). The ACAPS Group

Asymptomatic Carotid Artery Plaque Study (ACAPS) Group

doi:10.1016/0197-2456(92)90012-o

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Journal article

Rationale and design for the Asymptomatic Carotid Artery Plaque Study (ACAPS). The ACAPS Group

Asymptomatic Carotid Artery Plaque Study (ACAPS) Group

Controlled clinical trials, Vol.13(4), pp.293-314

08/1992

DOI: 10.1016/0197-2456(92)90012-o

PMID: 1330434

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Abstract

An NHLBI-sponsored randomized, double-masked, placebo-controlled, multicenter clinical trial is underway to test the efficacy of the lipid-lowering agent lovastatin and/or the antithrombotic agent warfarin in slowing the progression of early carotid atherosclerosis--as defined by ultrasonographic intimal-medial arterial wall thickening--in a high-risk, asymptomatic population consisting of 919 men and women aged 40-79 years with moderately elevated serum LDL-cholesterol. The Asymptomatic Carotid Artery Plaque Study's (ACAPS) factorial design permits evaluation of each of the two treatments alone as well as assessment of the treatments in combination with each other over a 2.5- to 3.0-year treatment period. Randomized participants receive either 20-40 mg/day lovastatin or lovastatin placebo and either 1 mg/day (minidose) warfarin or warfarin placebo. All participants were encouraged to take low-dose (81 mg/day) aspirin. The primary outcome is the ultrasonographic measurement of the mean of maximum intimal-medial thickness (IMT) across up to 12 preselected segments in the carotid arteries. The secondary outcome of the trial measures the single maximum IMT measurement among the same preselected carotid artery segments. This report describes the rationale for ACAPS, its design, and some baseline characteristics of the study population.

Ultrasonography

Carotid Artery Diseases - prevention & control

Lovastatin - therapeutic use

Arteriosclerosis - drug therapy

Humans

Middle Aged

Risk Factors

Male

Statistics as Topic

Warfarin - administration & dosage

Warfarin - therapeutic use

Carotid Artery Diseases - diagnostic imaging

Adult

Female

Aged

Lovastatin - administration & dosage

Patient Compliance

Drug Therapy, Combination

Research Design

Carotid Artery Diseases - drug therapy

Details

Title: Subtitle: Rationale and design for the Asymptomatic Carotid Artery Plaque Study (ACAPS). The ACAPS Group
Creators: Asymptomatic Carotid Artery Plaque Study (ACAPS) Group
Contributors: Harold P Adams Jr (Contributor) - University of Iowa, Neurology
Resource Type: Journal article
Publication Details: Controlled clinical trials, Vol.13(4), pp.293-314
Publisher: United States
DOI: 10.1016/0197-2456(92)90012-o
PMID: 1330434
ISSN: 0197-2456
eISSN: 1879-050X
Grant note: 5R01HL38194 / NHLBI NIH HHS
Language: English
Date published: 08/1992
Academic Unit: Neurology; Iowa Neuroscience Institute
Record Identifier: 9984020773702771

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