| The Cholesterol Lowering Atherosclerosis Study (CLAS): design, methods, and baseline results. | |
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MedLine Citation:
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PMID: 3327654 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The Cholesterol Lowering Atherosclerosis Study (CLAS) is a prospective, placebo-controlled, angiographic trial designed to test the hypothesis that aggressive lowering of LDL cholesterol with concomitant increase in HDL cholesterol will reverse or retard the atherosclerotic process. Specifically, CLAS was designed to determine whether combined therapy with colestipol plus niacin will produce clinically significant change in coronary, carotid, and femoral artery atherosclerosis and coronary bypass graft lesions. To this purpose, 188 subjects were randomized to diet plus drug or diet plus placebo. We report on methodological aspects of planning and evaluating this study, including the choice of the study population, procedures for recruitment, the experimental design including sample size considerations, methods for evaluating outcome, and methods for evaluating compliance to treatment. Comparison of baseline data indicated no significant differences between groups at the time of randomization. Subjects were predominantly male, Caucasian, 54 years of age, 20% above ideal weight, with normal blood pressure. The average age at bypass was 50 years. The average lipids were cholesterol (243 mg/dL), HDL (45 mg/dL), and LDL (168 mg/dL). Finally, the distribution of baseline coronary stenosis was equivalent between the two groups (average number of lesions per subject = 10.6). |
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Authors:
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D H Blankenhorn; R L Johnson; S A Nessim; S P Azen; M E Sanmarco; R H Selzer |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Controlled clinical trials Volume: 8 ISSN: 0197-2456 ISO Abbreviation: Control Clin Trials Publication Date: 1987 Dec |
Date Detail:
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Created Date: 1988-04-28 Completed Date: 1988-04-28 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8006242 Medline TA: Control Clin Trials Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 356-87 Citation Subset: IM |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Angiography Arteriosclerosis / radiography, therapy* California Cholesterol, Dietary / administration & dosage Cholesterol, LDL / blood* Clinical Trials as Topic Colestipol / therapeutic use Dietary Fats / administration & dosage Humans Male Middle Aged Niacin / therapeutic use Prospective Studies Random Allocation Research Design |
| Grant Support | |
ID/Acronym/Agency:
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R01-HL-23619/HL/NHLBI NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Cholesterol, Dietary; 0/Cholesterol, LDL; 0/Dietary Fats; 50925-79-6/Colestipol; 59-67-6/Niacin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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