Coronary Drug Project
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| ClinicalTrials.gov Identifier: NCT00000482 |
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Recruitment Status :
Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Myocardial Ischemia | Drug: estrogen Drug: clofibrate clofibrate Drug: dextrothyroxine sodium Drug: niacin | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Masking: | Double |
| Primary Purpose: | Prevention |
| Study Start Date : | April 1965 |
| Actual Study Completion Date : | March 1985 |
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| Ages Eligible for Study: | 30 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000482
| OverallOfficial: | Paul Canner | University of Maryland, College Park |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00000482 History of Changes |
| Other Study ID Numbers: |
1 R01HL008888-14 ( Other Grant/Funding Number: US NIH Grant Number ) |
| First Posted: | October 28, 1999 Key Record Dates |
| Last Update Posted: | November 26, 2013 |
| Last Verified: | July 2004 |
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Heart Diseases Myocardial Infarction Coronary Disease Myocardial Ischemia Infarction Ischemia Cardiovascular Diseases Pathologic Processes Necrosis Vascular Diseases |
Clofibrate Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Anticholesteremic Agents |