Coronary drug project: Difference between revisions
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==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"|'''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 | ||
|- | |- | ||
| '''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'''|| | | '''Condition'''||Cardiovascular diseases; coronary disease; heart diseases; myocardial infarction; myocardial ischemia | ||
|- | |- | ||
| '''Intervention'''|| | | '''Intervention'''||Drug: estrogen<br> | ||
Drug: clofibrate clofibrate<br> | |||
Drug: dextrothyroxine sodium<br> | |||
Drug: niacin | |||
|- | |- | ||
| '''Study Arms'''|| | | '''Study Arms'''|| | ||
Revision as of 18:28, 18 August 2014
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High Density Lipoprotein Microchapters |
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Diagnosis |
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Treatment |
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Clinical Trials |
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Case Studies |
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Coronary drug project On the Web |
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American Roentgen Ray Society Images of Coronary drug project |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]
Official Title
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
National Heart, Lung, and Blood Institute (NHLBI)
Timeline
| Timeline | |
| Start Date | |
| End Date | |
| Status | |
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 |
| Study Arms | |
| Population Size | |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00000482.
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Outcomes
Primary Outcomes
Publications
Results
Conclusion
Pending