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| ID | Type | Description | Link |
|---|---|---|---|
| KUMSEC-2001-035 |
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Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. The purpose of this study is to determine whether early (within 96 hours after onset) use of any available statins are effective to prevent cardiovascular events including heart failure after acute myocardial infarction in Japanese patients.
At least, in Japanese, it was controversial if lipid-lowering therapy to the patients whose total cholesterol levels <240 mg/dL was needed. Furthermore, in general, a role for early statin therapy in patients with ST-elevated AMI reperfused by primary PCI has not been clearly established. Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. A prospective, randomized, open-label, multicenter trial is conducted in AMI patients with normal total cholesterol levels (180-240 mg/dL). Patients are randomly assigned to receive any available statin within 96 hours of AMI onset or no statin and were followed for up to 24 months. The primary endpoint is a composite of cardiovascular death, nonfatal AMI, recurrent symptomatic myocardial ischemia, congestive heart failure, and stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statins | Active Comparator |
| |
| No statins | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lipid-lowering treatment | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| A combination of: cardiovascular death | ||
| nonfatal acute myocardial infarction | ||
| recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization | ||
| congestive heart failure requiring emergent rehospitalization | ||
| and nonfatal stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Reintervention procedures: coronary artery bypass grafting (CABG) | ||
| percutaneous coronary intervention (PCI) for a new lesion | ||
| and repeat PCI procedures for restenosis of the infarct-related or non-infarct-related lesions (repeat PCI occurring in the first 6 months of follow-up for an index lesion was excluded) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hisao Ogawa, M.D., Ph.D. | Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Medicine, Kumamoto University Hospital | Kumamoto | Kumamoto | 860-8556 | Japan |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |