Coronary Drug Project
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): estrogen; clofibrate clofibrate; dextrothyroxine sodium; niacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Niacin; Clofibrate; Estrogens
Allocation: Randomized
Masking: Double
Primary purpose: Prevention