Coronary Drug Project
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
estrogen
clofibrate clofibrate
dextrothyroxine sodium
niacin
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Men, ages 30-64. Three months beyond most recent myocardial infarction.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000482
First Posted
October 27, 1999
Last Updated
November 25, 2013
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000482
Brief Title
Coronary Drug Project
Study Type
Interventional
2. Study Status
Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
April 1965 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 1985 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
estrogen
Intervention Type
Drug
Intervention Name(s)
clofibrate clofibrate
Intervention Type
Drug
Intervention Name(s)
dextrothyroxine sodium
Intervention Type
Drug
Intervention Name(s)
niacin
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men, ages 30-64. Three months beyond most recent myocardial infarction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Canner
Organizational Affiliation
University of Maryland
12. IPD Sharing Statement
Citations:
Citation
Coronary Drug Project Enters Enrollment Phase (Medical News). JAMA, 200:37-38, l967.
Results Reference
background
Citation
Parsons, W. Coronary Drug Project Deserves Support of Nation's Physicians. Cardiology Digest, January l967, pp. l3-l6.
Results Reference
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Citation
Coronary Drug Project, Publication l695. National Heart Institute, Public Health Service, l968.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
4320008
Citation
The Coronary Drug Project. Initial findings leading to modifications of its research protocol. JAMA. 1970 Nov 16;214(7):1303-13. No abstract available.
Results Reference
background
Citation
Heart Drug Project Yields Good Results (Medical News). JAMA, 2l3:954-956, l970.
Results Reference
background
PubMed Identifier
4337170
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. No abstract available.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
4117098
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. doi: 10.7326/0003-4819-77-5-677. No abstract available.
Results Reference
background
PubMed Identifier
4570454
Citation
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.
Results Reference
background
PubMed Identifier
4119817
Citation
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.
Results Reference
background
PubMed Identifier
4356847
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. No abstract available.
Results Reference
background
PubMed Identifier
4275188
Citation
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.
Results Reference
background
PubMed Identifier
4610000
Citation
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.
Results Reference
background
PubMed Identifier
4138758
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. No abstract available.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
1088963
Citation
Clofibrate and niacin in coronary heart disease. JAMA. 1975 Jan 27;231(4):360-81. No abstract available.
Results Reference
background
Citation
Coronary Drug Project Research Group: Reply to Letter to the Editor from D.J. Gans. JAMA, 234:22-23, l975.
Results Reference
background
PubMed Identifier
956335
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. doi: 10.1016/0021-9681(76)90003-5. No abstract available.
Results Reference
background
PubMed Identifier
789390
Citation
Aspirin in coronary heart disease. The Coronary Drug Project Research Group. J Chronic Dis. 1976 Oct;29(10):625-42.
Results Reference
background
PubMed Identifier
323090
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.
Results Reference
background
PubMed Identifier
195293
Citation
Wenger NK, Stamler J. The Coronary Drug Project: implications for clinical care. Prim Care. 1977 Jun;4(2):247-53. No abstract available.
Results Reference
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PubMed Identifier
323705
Citation
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.
Results Reference
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PubMed Identifier
349581
Citation
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.
Results Reference
background
PubMed Identifier
356579
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. doi: 10.1016/0002-9149(78)90946-3.
Results Reference
background
PubMed Identifier
457827
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. doi: 10.1016/0021-9681(79)90102-4. No abstract available.
Results Reference
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PubMed Identifier
6999345
Citation
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.
Results Reference
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PubMed Identifier
7002353
Citation
Aspirin in coronary heart disease. The Coronary Drug Project Research Group. Circulation. 1980 Dec;62(6 Pt 2):V59-62.
Results Reference
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PubMed Identifier
7014029
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. doi: 10.1161/01.cir.63.6.1342. No abstract available.
Results Reference
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PubMed Identifier
7261627
Citation
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.
Results Reference
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PubMed Identifier
7094247
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. doi: 10.1161/01.cir.66.2.401. No abstract available.
Results Reference
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PubMed Identifier
6501718
Citation
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.
Results Reference
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PubMed Identifier
29506561
Citation
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.
Results Reference
derived
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Coronary Drug Project
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