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

Kumamoto University

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: lipid-lowering treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00128024

KUMSEC-2001-035

CVM-RCT-2001-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 460 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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460 participants in 2 patient groups

Statins

Active Comparator group

Treatment:

Drug: lipid-lowering treatment

No statins

No Intervention group