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

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: lipid-lowering treatment

• Registration Number: NCT00128024
• Lead Sponsor: Kumamoto University

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2004-02
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-09
• Study Completion: 2006-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-17
• Last Update Posted: 2013-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statins	lipid-lowering treatment	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Cardiovascular Medicine, Kumamoto University Hospital; 🇯🇵 Kumamoto, Japan