Coronary Drug Project Mortality Surveillance
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Purpose
To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).
status: completed conditions: Cardiovascular Diseases ; Coronary Disease ; Heart Diseases ; Myocardial Infarction ; Myocardial Ischemia interventions: estrogen ; clofibrate ; dextrothyroxine sodium ; niacin phase: N/A study type: Interventional study design: Prevention, Randomized -
Further study details (as provided by National Heart, Lung, and Blood Institute (NHLBI))
study start date: June 1981
Detailed description
BACKGROUND:
Three of the CDP treatments (two doses of estrogen and dextrothyroxine) were stopped prematurely because of toxicity. At the time the treatments were stopped, it was thought that future assessment of the status of patients on those treatments would be important to evaluate long-term sequellae. Another clinical trial evaluating clofibrate for primary prevention found that more patients on that treatment than on placebo had died. This effect persisted even after the treatment was stopped. Therefore, it was considered necessary to follow the CDP patients on clofibrate.
Of the original 834l patients, about 6000 were still alive in March l975. Cause-specific mortality in those patients was assessed through March l980.
DESIGN NARRATIVE:
The vital status of the subjects known to be alive at the end of the CDP in March l975 was assessed as of March l980. This was accomplished through questioning the local investigators, letters to the subjects, and by use of Social Security Administration and National Death Index records.
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Eligibility
ages eligible for study: 30 Years to 64 Years genders eligible for study: Male Criteria
No eligibility criteria -
Contacts and locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000483
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Sponsors and collaborators
National Heart, Lung, and Blood Institute (NHLBI)
investigators: Roger Sherwin, University of Maryland
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More information
Other publications
Canner PL, Klimt CR. The Coronary Drug Project. Experimental design features. Control Clin Trials. 1983 Dec;4(4):313-32. No abstract available.
Canner PL, Stamler J. The Coronary Drug Project. Organizational structure of the study. Control Clin Trials. 1983 Dec;4(4):333-43. No abstract available.
Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol. 1986 Dec;8(6):1245-55.
Berge KG, Canner PL. Coronary drug project: experience with niacin. Coronary Drug Project Research Group. Eur J Clin Pharmacol. 1991;40 Suppl 1:S49-51.
first received: October 27, 1999 last updated: June 23, 2005 ClinicalTrials.gov Identifier: NCT00000483 health authority: United States: Federal Government
Information obtained from ClinicalTrials.gov on September 25, 2009 Link to the current ClinicalTrials.gov record.
