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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128024
• Other study ID #: CVM-RCT-2001-02
• Secondary ID: KUMSEC-2001-035
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2005
• Last updated: April 17, 2013
• Start date: February 2002
• Est. completion date: February 2006

Study information

• Verified date: April 2013
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: February 2006
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• lipid-lowering treatment

Locations

Country	Name	City	State
Japan	Department of Cardiovascular Medicine, Kumamoto University Hospital	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A combination of: cardiovascular death
Primary	nonfatal acute myocardial infarction
Primary	recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization
Primary	congestive heart failure requiring emergent rehospitalization
Primary	and nonfatal stroke
Secondary	Reintervention procedures: coronary artery bypass grafting (CABG)
Secondary	percutaneous coronary intervention (PCI) for a new lesion
Secondary	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)