Completed

Coronary Drug Project Mortality Surveillance

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What is being tested

estrogen

+ clofibrate
+ dextrothyroxine sodium
Drug
Who is being recruted

Cardiovascular Diseases
+2

+ Coronary Disease
+ Heart Diseases
From 30 to 64 Years
How is the trial designed

Prevention Study

Interventional
Study Start: June 1981

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: November 26, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 1981Actual date on which the first participant was enrolled.

To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate). 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.

Official TitleCoronary Drug Project Mortality Surveillance 
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: November 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
From 30 to 64 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Criteria

No eligibility criteria



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers