Coronary Drug Project Mortality Surveillance
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
estrogen
clofibrate
dextrothyroxine sodium
niacin
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000483
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
NCT00000483
Brief Title
Coronary Drug Project Mortality Surveillance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
June 1981 (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 there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).
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.
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
Not Applicable
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
estrogen
Intervention Type
Drug
Intervention Name(s)
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
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Sherwin
Organizational Affiliation
University of Maryland
12. IPD Sharing Statement
Citations:
PubMed Identifier
6675887
Citation
Canner PL, Klimt CR. The Coronary Drug Project. Experimental design features. Control Clin Trials. 1983 Dec;4(4):313-32. doi: 10.1016/0197-2456(83)90019-3. No abstract available.
Results Reference
background
PubMed Identifier
6675888
Citation
Canner PL, Stamler J. The Coronary Drug Project. Organizational structure of the study. Control Clin Trials. 1983 Dec;4(4):333-43. doi: 10.1016/0197-2456(83)90020-x. No abstract available.
Results Reference
background
PubMed Identifier
3782631
Citation
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. doi: 10.1016/s0735-1097(86)80293-5.
Results Reference
background
PubMed Identifier
2044644
Citation
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.
Results Reference
background
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Coronary Drug Project Mortality Surveillance
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