Coronary Drug Project

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000482
• Other study ID #: 1
• Secondary ID: R01HL008888-14
• Status: Completed
• Phase: Phase 3
• First received: October 27, 1999
• Last updated: November 25, 2013
• Start date: April 1965
• Est. completion date: March 1985

Study information

• Verified date: July 2004
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 1985
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 64 Years
• Eligibility: Men, ages 30-64. Three months beyond most recent myocardial infarction.

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

Intervention

Drug:
• estrogen

• clofibrate clofibrate

• dextrothyroxine sodium

• niacin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (33)

Aspirin in coronary heart disease. The Coronary Drug Project Research Group. Circulation. 1980 Dec;62(6 Pt 2):V59-62. — View Citation

Aspirin in coronary heart disease. The Coronary Drug Project Research Group. J Chronic Dis. 1976 Oct;29(10):625-42. — View Citation

Blood pressure in survivors of myocardial infarction. The Coronary Drug Project Research Group. J Am Coll Cardiol. 1984 Dec;4(6):1135-47. — View Citation

Canner PL, Halperin M. Implications of findings in the coronary drug project for secondary prevention trials in coronary heart disease. The coronary; drug project research group. Circulation. 1981 Jun;63(6):1342-50. — View Citation

Cigarette smoking as a risk factor in men with a prior history of myocardial infarction. The Coronary Drug Project Research Group. J Chronic Dis. 1979;32(6):415-25. — View Citation

Clofibrate and niacin in coronary heart disease. JAMA. 1975 Jan 27;231(4):360-81. — View Citation

Coronary Drug Project Enters Enrollment Phase (Medical News). JAMA, 200:37-38, l967.

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.

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.

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: 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 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, Publication l695. National Heart Institute, Public Health Service, l968.

Factors influencing long-term prognosis after recovery from myocardial infarction--three-year findings of the coronary drug project. J Chronic Dis. 1974 Aug;27(6):267-85. — View Citation

Gallbladder disease as a side effect of drugs influencing lipid metabolism. Experience in the Coronary Drug Project. N Engl J Med. 1977 May 26;296(21):1185-90. — View Citation

Gans DJ. Letter: Coronary drug project. JAMA. 1975 Oct 6;234(1):21-2. — View Citation

Heart Drug Project Yields Good Results (Medical News). JAMA, 2l3:954-956, l970.

Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project. N Engl J Med. 1980 Oct 30;303(18):1038-41. — View Citation

Left ventricular hypertrophy patterns and prognosis. Experience postinfarction in the Coronary Drug Project. Circulation. 1974 May;49(5):862-9. — View Citation

Natural history of myocardial infarction in the coronary drug project: long-term prognostic importance of serum lipid levels. Coronary Drug Project Research Group. Am J Cardiol. 1978 Sep;42(3):489-98. — View Citation

Parsons, W. Coronary Drug Project Deserves Support of Nation's Physicians. Cardiology Digest, January l967, pp. l3-l6.

Practical aspects of decision making in clinical trials: the coronary drug project as a case study. The Coronary Drug Project Research Group. Control Clin Trials. 1981 May;1(4):363-76. — View Citation

Prognostic importance of premature beats following myocardial infarction. Experience in the coronary drug project. JAMA. 1973 Mar 5;223(10):1116-24. — View Citation

Schlant RC, Forman S, Stamler J, Canner PL. The natural history of coronary heart disease: prognostic factors after recovery from myocardial infarction in 2789 men. The 5-year findings of the coronary drug project. Circulation. 1982 Aug;66(2):401-14. — View Citation

Serum uric acid: its association with other risk factors and with mortality in coronary heart disease. J Chronic Dis. 1976 Sep;29(9):557-69. — View Citation

The coronary drug project aspirin study. Implications for clinical care. Coronary Drug Project Research Group. Prim Care. 1978 Mar;5(1):91-5. — View Citation

The Coronary Drug Project. Findings leading to discontinuation of the 2.5-mg day estrogen group. The coronary Drug Project Research Group. JAMA. 1973 Nov 5;226(6):652-7. — View Citation

The coronary drug project. Findings leading to further modifications of its protocol with respect to dextrothyroxine. The coronary drug project research group. JAMA. 1972 May 15;220(7):996-1008. — View Citation

The Coronary Drug Project. Initial findings leading to modifications of its research protocol. JAMA. 1970 Nov 16;214(7):1303-13. — View Citation

The prognostic importance of plasma glucose levels and of the use of oral hypoglycemic drugs after myocardial infarction in men. Diabetes. 1977 May;26(5):453-65. — View Citation

The prognostic importance of premature ventricular complexes in the late post-infarction period. Experience in the Cornary Drug Project. Acta Cardiol. 1974;Suppl 18:33-53. — View Citation

The prognostic importance of the electrocardiogram after myocardial infarction. Experience in the Coronary Drug Project. Ann Intern Med. 1972 Nov;77(5):677-89. — View Citation

Wenger NK, Stamler J. The Coronary Drug Project: implications for clinical care. Prim Care. 1977 Jun;4(2):247-53. — View Citation

* Note: There are 33 references in all — Click here to view all references