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

NCT ID: NCT00128024

Last Updated: 2013-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2006-02-28

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Statins

Group Type: ACTIVE_COMPARATOR

lipid-lowering treatment

Intervention Type: DRUG

No statins

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

lipid-lowering treatment

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kumamoto University

OTHER

Sponsor Role: lead

Responsible Party

Hisao Ogawa

Pofessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hisao Ogawa, M.D., Ph.D.

Role: STUDY_CHAIR

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Locations

Department of Cardiovascular Medicine, Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Countries

Japan

Other Identifiers

KUMSEC-2001-035

Identifier Type: -

Identifier Source: secondary_id

CVM-RCT-2001-02

Identifier Type: -

Identifier Source: org_study_id