Effects of Early Statin Treatment After Acute Myocardial Infarction (AMI) in Japanese Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Early Statin Treatment on Symptomatic Heart Failure and Ischemic Events After Acute Myocardial Infarction. The MUSASHI-AMI: A Multicenter Randomized Controlled Trial

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: lipid-lowering treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of acute myocardial infarction Serum total cholesterol levels on admission ranges ≥180 mg/dL and <240 mg/dL Exclusion Criteria: Age < 18 years Time from symptom onset to admission > 96 hours Use of lipid-lowering agents within the previous 3 months Known familial dyslipidemia Severe renal failure Known hepatic disease Signs and symptoms of severe heart failure (Killip class III or IV) A scheduled PCI or coronary artery bypass grafting (CABG) A history of previous PCI (within 6 months) or CABG (within 3 months) The presence of malignant disease The presence of allergy to statins.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Statins<br> | Drug: lipid-lowering treatment<br> <br> |
| No Intervention: No statins<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized prospective study, lipid-lowering therapy with any available statins, multicenter study, Japanese, acute myocardial infarction, primary percutaneous coronary intervention