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==Official Title==
==Official Title==
 
Coronary Drug Project


==Objective==
==Objective==
 
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.


==Sponsor==
==Sponsor==
 
National Heart, Lung, and Blood Institute (NHLBI)


==Timeline==
==Timeline==
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| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline'''
| Colspan="2" style="background:Gainsboro" align="center"|'''Timeline'''
|-
|-
| Style="width:30%"| '''Start Date'''||Style="width:70%"|
| Style="width:30%"| '''Start Date'''||Style="width:70%"|April 1965
|-
|-
| '''End Date'''||
| '''End Date'''||March 1985
|-
|-
| '''Status'''||
| '''Status'''||Completed
|-
|-
|}
|}
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| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description'''
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Description'''
|-
|-
| Style="width:30%"|'''Study Type'''|| Style="width:70%"|
| Style="width:30%"|'''Study Type'''|| Style="width:70%"|Interventional
|-
|-
| '''Study Phase''' ||
| '''Study Phase''' || Phase 3
|-
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design'''
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Design'''
|-
|-
| '''Allocation'''||
| '''Allocation'''||Randomized
|-
| '''Endpoint'''||
|-
| '''Interventional Model'''||
|-
|-
| '''Masking'''||
| '''Masking'''||Double-Blind
|-
|-
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details'''
| Colspan="2" style="background:Gainsboro" align="center"|'''Study Details'''
|-
|-
| '''Primary Purpose'''||
| '''Primary Purpose'''||Prevention
|-
| '''Condition'''||
|-
|-
| '''Intervention'''||
| '''Condition'''||Cardiovascular diseases; coronary disease; heart diseases; myocardial infarction; myocardial ischemia
|-
|-
| '''Study Arms'''||
| '''Intervention'''||Drug: estrogen<br>
Drug: clofibrate clofibrate<br>
Drug: dextrothyroxine sodium<br>
Drug: niacin
|-
|-
| '''Population Size'''||
| '''Population Size'''||8,341 subjects
|-
|-
|}
|}
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==Eligibility Criteria==
==Eligibility Criteria==
===Inclusion Criteria===
===Inclusion Criteria===
 
Men, ages 30-64, three months beyond most recent myocardial infarction
===Exclusion Criteria===
 
==Outcomes==
===Primary Outcomes===
 
==Publications==
===Results===
 
===Conclusion===
Pending


==References==
==References==

Latest revision as of 20:19, 18 August 2014

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]

Official Title

Coronary Drug Project

Objective

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.

National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Timeline
Start Date April 1965
End Date March 1985
Status Completed

The previous information was derived from ClinicalTrials.gov on 08/18/2014 using the identification number NCT00000482.

Study Description

Study Description
Study Type Interventional
Study Phase Phase 3
Study Design
Allocation Randomized
Masking Double-Blind
Study Details
Primary Purpose Prevention
Condition Cardiovascular diseases; coronary disease; heart diseases; myocardial infarction; myocardial ischemia
Intervention Drug: estrogen

Drug: clofibrate clofibrate
Drug: dextrothyroxine sodium
Drug: niacin

Population Size 8,341 subjects

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00000482.

Eligibility Criteria

Inclusion Criteria

Men, ages 30-64, three months beyond most recent myocardial infarction

References