Trial record 3 of 412 for:    Cerebral Arteriosclerosis

Cholesterol-Lowering Atherosclerosis Study (CLAS)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000599
First received: October 27, 1999
Last updated: December 12, 2013
Last verified: May 2000
  Purpose

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.


Condition Intervention Phase
Arterial Occlusive Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebral Arteriosclerosis
Cerebrovascular Disorders
Coronary Arteriosclerosis
Coronary Disease
Heart Diseases
Myocardial Ischemia
Atherosclerosis
Drug: colestipol
Drug: niacin
Behavioral: diet, fat-restricted
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: June 1980
Study Completion Date: November 1994
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.

  Eligibility

Ages Eligible for Study:   40 Years to 59 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000599

Sponsors and Collaborators
Investigators
Investigator: Stanley Azen University of Southern California
Investigator: David Blankenhorn University of Southern California
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00000599     History of Changes
Other Study ID Numbers: 502, P01HL023619
Study First Received: October 27, 1999
Last Updated: December 12, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Intracranial Arteriosclerosis
Brain Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Vascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Intracranial Arterial Diseases
Colestipol
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Sequestering Agents

ClinicalTrials.gov processed this record on August 27, 2014