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Cholesterol-Lowering Atherosclerosis Study (CLAS)

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ClinicalTrials.gov Identifier: NCT00000599
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : December 13, 2013
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE October 27, 1999
First Posted Date  ICMJE October 28, 1999
Last Update Posted Date December 13, 2013
Study Start Date  ICMJE June 1980
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cholesterol-Lowering Atherosclerosis Study (CLAS)
Official Title  ICMJE Not Provided
Brief Summary To determine whether combined therapy with the lipid lowering agents colestipol hydrochloride plus niacin would produce significant change in coronary, carotid, and femoral artery atherosclerosis and coronary bypass graft lesions as determined by angiography. Also, to determine possible correlations between lesion changes and plasma lipid and lipoprotein cholesterol levels and to explore interrelationships of atherosclerosis change in femoral, coronary, and carotid arteries.
Detailed Description

BACKGROUND:

The Lipid Research Clinics Coronary Primary Prevention Trial and the Coronary Drug Project had shown that morbidity and mortality from ischemic heart disease were reduced by blood cholesterol-lowering therapy. Although blood cholesterol reduction ameliorated experimental atherosclerosis in animal models, the two largest human studies with angiographic observation of arterial lesion change, the NHLBI Type II Coronary Intervention Study and a study by Cohn et al, had not demonstrated significant treatment effects. Favorable, but inconclusive, treatment trends were observed in four unrandomized angiographic trials and one trial too small for evaluation of randomized groups.

The clinical trial was supported by a subproject within a program project grant.

DESIGN NARRATIVE:

CLAS-I was randomized and selectively-blinded. Screening for the trial consisted of five clinic visits, at which baseline data, including angiographic data, were obtained and a prerandomization trial of the study drugs was conducted. One hundred eighty-eighty subjects were randomized to either 30 grams (g) of colestipol hydrochloride plus 3 to 12 g of niacin daily or to placebo. Both groups received diet intervention. The drug group received less than 125 milligrams (mg) of cholesterol daily, 22 percent of energy as fat, 10 percent as polyunsaturated fat, and 4 percent as saturated fat. The placebo group received less than 250 mg of cholesterol per day, 26 percent of energy as fat, 10 percent as polyunsaturated fat, and 5 percent as saturated fat. The different diet composition for drug and placebo groups was to enhance the differential in blood cholesterol responses between the two groups. Study subjects and clinic staff were blinded to the prerandomization study drug trial lipid responses. Subjects were blinded to treatment assignments. Subjects and staff were not blinded to on-trial lipid values. The primary endpoint, the global change score, was change in atherosclerosis observed by angiography of native coronary arteries and aorta coronary bypass grafts. Evaluation of study end-points was performed by staff and consultants who were blinded to treatment group assignments, as well as to the temporal ordering of angiographic data. Subjects were seen monthly for the first six months and then at two-month intervals. A repeat angiogram was performed at two years. Of the 188 randomized subjects, 162 completed the study.

On completion of CLAS-I, participants not requiring further bypass surgery were invited to continue in CLAS-II for an additional two years on their previously assigned treatment. Blinded study methods were maintained; there was no crossover between treatments. One hundred thirty-eight subjects continued in CLAS-II; 103 completed a third angiogram before the CLAS-I outcome was known and CLAS-II terminated. The CLAS-II clinical procedures, lipid, lipoprotein-cholesterol, and apolipoprotein analyses were the same as in CLAS-I. The CLAS-II angiographic and file evaluation procedures exactly replicated those in CLAS-I.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Arterial Occlusive Diseases
  • Cardiovascular Diseases
  • Carotid Artery Diseases
  • Cerebral Arteriosclerosis
  • Cerebrovascular Disorders
  • Coronary Arteriosclerosis
  • Coronary Disease
  • Heart Diseases
  • Myocardial Ischemia
  • Atherosclerosis
Intervention  ICMJE
  • Drug: colestipol
  • Drug: niacin
  • Behavioral: diet, fat-restricted
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 1994
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Non-smoking men, ages 40 to 59, with progressive atherosclerosis confirmed by angiography, who had coronary bypass surgery at least three months prior to the study admission date, and who had entry fasting blood cholesterol levels in the range of 185
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000599
Other Study ID Numbers  ICMJE 502
P01HL023619 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Stanley Azen University of Southern California
Investigator: David Blankenhorn University of Southern California
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date May 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP