Coronary Drug Project

Cardiovascular Diseases Clinical Trial

Status Completed

Clinical Trial Summary

To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Secondarily, to determine whether the degree to which these drugs changed serum lipids was correlated with any effect on mortality and morbidity rates; to gain further information on the long-term prognosis of myocardial infarction (by studying the control group as intensively as the treatment group); to acquire further experience and knowledge concerning the techniques and methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.

Clinical Trial Description

BACKGROUND:

Correlation of high levels of serum cholesterol with an increased incidence and prevalence of coronary heart disease (CHD) was demonstrated--prior to the inception of the Coronary Drug Project--repeatedly in prospective and cross-sectional epidemiological surveys (e.g., the Tecumseh Study, the Framingham Heart Disease Study). These findings led to the question of whether long-term lowering of serum lipids in individuals both with and without CHD would have a beneficial effect on morbidity and mortality.

The Coronary Drug Project was designed to answer the question of secondary prevention. In 1961, Dr. Robert Wilkins (Boston University School of Medicine) chaired an ad hoc committee which determined the desirability and feasibility of the conduct of this study. Following National Heart Advisory Council (NHAC) support, a study Policy Board, Steering Committee, and Coordinating Center were established and a detailed protocol was written.

In 1964, NHAC approved the project and the NHI recommendation for implementation; the study was begun in 1965. Supported by the grant mechanism, the trial involved 53 participating clinics, a coordinating center, central laboratory, ECG center, drug procurement and distribution center, and NHI medical liaison office, and a policy board, steering committee, and 12 other committees (e.g., a data and safety monitoring committee).

The first patient was randomly allocated to treatment in March 1966 and the last in October 1969. Each patient reported to the clinic every 4 months for a follow-up visit.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. A total of 8,341 patients were randomly assigned to six treatment groups consisting of 2.5 mg/day of conjugated estrogens, 5.0 mg/day of conjugated estrogens, 1.8 gm/day of clofibrate, 6.0 mg/day of dextrothyroxine sodium, 3.0 gm/day of niacin, or 3.8 gm/day of lactose placebo.

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Infarction
• Myocardial Ischemia

• NCT number: NCT00000482
• Study type: Interventional
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Status: Completed
• Phase: Phase 3
• Start date: April 1965
• Completion date: March 1985