Lipid Research Clinics Coronary Primary Prevention Trial (CPPT) - Tabular View

Tracking Information

First Received Date ^ICMJE

October 27, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

June 1973

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000488 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Lipid Research Clinics Coronary Primary Prevention Trial (CPPT)

Official Title ^ICMJE

Brief Summary

To determine whether reduction of cholesterol by drug therapy significantly lowered the atherosclerotic coronary heart disease rate in a group of hypercholesterolemic but otherwise healthy men.

Total dollars spent on the CPPT from June 1973 were $142,250,000. We do not have a year-by-year breakdown.

Detailed Description

BACKGROUND:

Numerous prospective epidemiologic studies have demonstrated that hypercholesterolemia is a major risk factor for atherosclerotic coronary heart disease. Research on animals indicating that the reduction of serum cholesterol prevented or reversed atherosclerosis had not been shown convincingly in humans. The Coronary Primary Prevention Trial tested the hypothesis that lowering the serum cholesterol in patients who had no existing evidence of coronary heart disease would reduce the subsequent rate of coronary heart disease in those persons.

Coronary heart disease is the leading cause of death and a major cause of morbidity in the United States. The very slow development of the underlying arterial disease and its frequently sudden onset and quickly fatal course necessitate a preventive approach if substantial inroads are to be made. The positive result from the Coronary Primary Prevention Trial (CPPT) has done much to resolve the controversy regarding the benefits of lipid-lowering, and should lead to firm advice for high-risk hypercholesterolemic subjects and for the population as a whole.

The CPPT was part of the Institute's Lipid Research Clinic Program under the Lipid Metabolism Branch, DHVD, NHLBI. Twelve lipid research clinics in the United States and Canada participated in this trial, as well as a coordinating center, a central electrocardiographic laboratory, central lipid and clinical chemistry laboratories, a nutrition coding center, and a group of consultants on recruitment and adherence. This program's objectives included the development of standardized methods and definitions for the diagnosis of hyperlipoproteinemia and the performance of a series of collaborative studies of the prevalence and natural history of this disorder, as well as the design and implementation of the Coronary Primary Prevention Trial.

The protocol for the trial was approved in November 1972. Beginning in July 1973, men with hypercholesterolemia were recruited as potential trial subjects from such diverse sources as physician referrals, blood bank donor lists, and mass screening programs. Each subject was screened further in a series of four visits, the purpose of which was to select only men (1) whose lipid abnormality was of the primary Type II phenotype, (2) who were free of clinically manifest coronary heart disease, and (3) whose excellent overall health and reliability made 7-10 years of follow-up a realistic objective. Additionally, a standardized limited-cholesterol/saturated fat diet was initiated at the second of these visits in order to exclude men whose cholesterol levels were highly responsive to diet. Subjects who met all the selection criteria were randomly assigned, in a double-blind fashion, to receive either the cholesterol-lowering drug cholestyramine or a placebo at their fifth visit.

Recruitment of the 3,806 CPPT subjects was completed in July 1976. After randomization into the study, each subject visited his clinic at bimonthly intervals. At these visits, adherence to drug and diet were assessed, the study medication was supplied, general health and potential toxic side effects were monitored, and intervening cardiovascular events were recorded. Counseling in drug and dietary adherence were given at each visit, and medical advice was given when a problem was identified. Trial data were collected and analyzed at the Central Patient Registry and reviewed periodically by a Safety and Data Monitoring Board. Intervention ceased between May and August 1983. A five-year follow-up was initiated in November 1984 to detect possible toxicity in the CPPT participants following ingestion of cholestyramine (or placebo) for 7 to 10 years. Follow-up was completed in October 1989.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample size with one experimental group and one control group of equal size. Experimental group on diet and lipid-lowering drug regimen; control group on diet and placebo regimen.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind

Condition ^ICMJE

Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Intervention ^ICMJE

Drug: cholestyramine
Behavioral: diet, fat-restricted

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Men, ages 35-59. Type II hyperlipoproteinemia. Free from coronary heart disease.

Gender

Male

Ages

35 Years to 59 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00000488

Responsible Party

Study ID Numbers ^ICMJE

Study Sponsor ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^ICMJE

Investigators ^ICMJE

Investigator:	Francois Abboud	University of Iowa
Investigator:	Elizabeth Barrett-Connor	University of California, San Diego
Investigator:	Reagan Bradford	Oklahoma Medical Research Foundation
Investigator:	Marilyn Buzzard	University of Minnesota
Investigator:	Gerald Cooper	Centers for Disease Control and Prevention
Investigator:	John Farquhar	Stanford University
Investigator:	Ivan Frantz	University of Minnesota
Investigator:	Anne Goldberg	Washington University School of Medicine
Investigator:	Frank Ibbott	Bio-Science Laboratories
Investigator:	William, Insull	Baylor College of Medicine
Investigator:	Robert Knoop	University of Washington
Investigator:	Peter Kwiterovich	Johns Hopkins University
Investigator:	John LaRosa	George Washington University
Investigator:	J. Little	University of Toronto
Investigator:	L. Sheffield	University of Alabama at Birmingham
Investigator:	Dennis Sprecher	University of Cincinnati

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

June 2000

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