Coronary Drug Project

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000482
First received: October 27, 1999
Last updated: November 25, 2013
Last verified: July 2004
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Drug: estrogen
Drug: clofibrate clofibrate
Drug: dextrothyroxine sodium
Drug: niacin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


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

Study Start Date: April 1965
Study Completion Date: March 1985
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.

  Eligibility

Ages Eligible for Study:   30 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Men, ages 30-64. Three months beyond most recent myocardial infarction.

  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: NCT00000482

Sponsors and Collaborators
Investigators
Investigator: Paul Canner University of Maryland
  More Information

Publications:
Coronary Drug Project Enters Enrollment Phase (Medical News). JAMA, 200:37-38, l967.
Parsons, W. Coronary Drug Project Deserves Support of Nation's Physicians. Cardiology Digest, January l967, pp. l3-l6.
Coronary Drug Project Research Group: Control of Hyperlipidemia: 4. Progress in Drug Trials of Secondary Prevention with Particular Reference to the Coronary Drug Project, in Jones, R.J. (ed), Atherosclerosis (Proceedings of the Second International Symposium). New York, Springer-Verlag, l970, pp. 586-595.
Heart Drug Project Yields Good Results (Medical News). JAMA, 2l3:954-956, l970.
Coronary Drug Project Research Group: The Natural History of Myocardial Infarction in the Coronary Drug Project: Prognostic Indicators Following Infarction, in Tibblin, G., Keys, A., Werko, L. (eds), Preventive Cardiology, Stockholm, Almqvist & Wiksell, l972, pp. 54-64.
Coronary Drug Project Research Group: The Coronary Drug Project: Design, Methods, and Baseline Results (AHA Monograph No. 38). Circulation, 47(suppl l):ll-l50, l973.
Coronary Drug Project Research Group: The Coronary Drug Project: A Secondary Prevention Trial, in Schettler, G. and Weizel, A. (eds), Atherosclerosis III. Berlin/New York, Springer-Verlag, l974, pp. 729-747.
Coronary Drug Project Research Group: Some Methodology for Relating Serial Observations to Mortality in Men with Coronary Heart Disease (Abstract). Am J Epidemiol, l00:529, l974.

ClinicalTrials.gov Identifier: NCT00000482     History of Changes
Other Study ID Numbers: 1, R01HL008888-14
Study First Received: October 27, 1999
Last Updated: November 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Heart Diseases
Infarction
Ischemia
Myocardial Infarction
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Necrosis
Clofibrate
Estrogens
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014