Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000482
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Coronary Drug Project
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 eg 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 8341 patients were randomly assigned to six treatment groups consisting of 25 mgday of conjugated estrogens 50 mgday of conjugated estrogens 18 gmday of clofibrate 60 mgday of dextrothyroxine sodium 30 gmday of niacin or 38 gmday of lactose placebo
The study completion date listed in this record was obtained from the QueryViewReport QVR System
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 eg 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 eg 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 8341 patients were randomly assigned to six treatment groups consisting of 25 mgday of conjugated estrogens 50 mgday of conjugated estrogens 18 gmday of clofibrate 60 mgday of dextrothyroxine sodium 30 gmday of niacin or 38 gmday of lactose placebo
The study completion date listed in this record was obtained from the QueryViewReport QVR System
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL008888-14 | OTHER_GRANT | US NIH Grant Number | None |