Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Study Classification
INTERVENTIONAL
Study Start Date
1965-04-30
Study Completion Date
1985-03-31
Brief Summary
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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
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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.
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.
Conditions
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Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Study Design
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Allocation Method
RANDOMIZED
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Interventions
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estrogen
Intervention Type
DRUG
clofibrate clofibrate
Intervention Type
DRUG
dextrothyroxine sodium
Intervention Type
DRUG
niacin
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
Men, ages 30-64. Three months beyond most recent myocardial infarction.
Minimum Eligible Age
30 Years
Maximum Eligible Age
64 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
lead
Principal Investigators
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Paul Canner
Role:
University of Maryland
References
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Coronary Drug Project Enters Enrollment Phase (Medical News). JAMA, 200:37-38, l967.
Reference Type
BACKGROUND
Parsons, W. Coronary Drug Project Deserves Support of Nation's Physicians. Cardiology Digest, January l967, pp. l3-l6.
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BACKGROUND
Coronary Drug Project, Publication l695. National Heart Institute, Public Health Service, l968.
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BACKGROUND
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.
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BACKGROUND
The Coronary Drug Project. Initial findings leading to modifications of its research protocol. JAMA. 1970 Nov 16;214(7):1303-13. No abstract available.
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BACKGROUND
Heart Drug Project Yields Good Results (Medical News). JAMA, 2l3:954-956, l970.
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BACKGROUND
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. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
The prognostic importance of the electrocardiogram after myocardial infarction. Experience in the Coronary Drug Project. Ann Intern Med. 1972 Nov;77(5):677-89. doi: 10.7326/0003-4819-77-5-677. No abstract available.
Reference Type
BACKGROUND
The coronary drug project. Design, methods, and baseline results. Circulation. 1973 Mar;47(3 Suppl):I1-50. doi: 10.1161/01.cir.47.3s1.i-1. No abstract available.
Reference Type
BACKGROUND
Prognostic importance of premature beats following myocardial infarction. Experience in the coronary drug project. JAMA. 1973 Mar 5;223(10):1116-24. doi: 10.1001/jama.1973.03220100016005. No abstract available.
Reference Type
BACKGROUND
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. No abstract available.
Reference Type
BACKGROUND
Left ventricular hypertrophy patterns and prognosis. Experience postinfarction in the Coronary Drug Project. Circulation. 1974 May;49(5):862-9. doi: 10.1161/01.cir.49.5.862. No abstract available.
Reference Type
BACKGROUND
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. doi: 10.1016/0021-9681(74)90091-5. No abstract available.
Reference Type
BACKGROUND
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. No abstract available.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
Clofibrate and niacin in coronary heart disease. JAMA. 1975 Jan 27;231(4):360-81. No abstract available.
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BACKGROUND
Coronary Drug Project Research Group: Reply to Letter to the Editor from D.J. Gans. JAMA, 234:22-23, l975.
Reference Type
BACKGROUND
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. doi: 10.1016/0021-9681(76)90003-5. No abstract available.
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BACKGROUND
Aspirin in coronary heart disease. The Coronary Drug Project Research Group. J Chronic Dis. 1976 Oct;29(10):625-42.
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BACKGROUND
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.
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BACKGROUND
Wenger NK, Stamler J. The Coronary Drug Project: implications for clinical care. Prim Care. 1977 Jun;4(2):247-53. No abstract available.
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BACKGROUND
Coronary Drug Project Research Group. 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. doi: 10.1056/NEJM197705262962101.
Reference Type
BACKGROUND
The coronary drug project aspirin study. Implications for clinical care. Coronary Drug Project Research Group. Prim Care. 1978 Mar;5(1):91-5. No abstract available.
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BACKGROUND
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. doi: 10.1016/0002-9149(78)90946-3.
Reference Type
BACKGROUND
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. doi: 10.1016/0021-9681(79)90102-4. No abstract available.
Reference Type
BACKGROUND
Coronary Drug Project Research Group. 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. doi: 10.1056/NEJM198010303031804.
Reference Type
BACKGROUND
Aspirin in coronary heart disease. The Coronary Drug Project Research Group. Circulation. 1980 Dec;62(6 Pt 2):V59-62.
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BACKGROUND
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. doi: 10.1161/01.cir.63.6.1342. No abstract available.
Reference Type
BACKGROUND
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. doi: 10.1016/0197-2456(81)90041-6.
Reference Type
BACKGROUND
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. doi: 10.1161/01.cir.66.2.401. No abstract available.
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BACKGROUND
Blood pressure in survivors of myocardial infarction. The Coronary Drug Project Research Group. J Am Coll Cardiol. 1984 Dec;4(6):1135-47. doi: 10.1016/s0735-1097(84)80132-1.
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BACKGROUND
Murray EJ, Hernan MA. Improved adherence adjustment in the Coronary Drug Project. Trials. 2018 Mar 5;19(1):158. doi: 10.1186/s13063-018-2519-5.
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DERIVED
Other Identifiers
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R01HL008888-14
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1
Identifier Type: -
Identifier Source: org_study_id