Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. We 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.

Condition	Intervention	Phase
Acute Myocardial Infarction	Drug: lipid-lowering treatment	Phase II

Further Study Details: 

Primary Outcomes: A combination of:; (1)cardiovascular death,; (2)nonfatal acute myocardial infarction,; (3)recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization,; (4)congestive heart failure requiring emergent rehospitalization, and; (5)nonfatal stroke.
Secondary Outcomes: Reintervention procedures:; CABG, 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)
Expected Total Enrollment:  460

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. We 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Japan
      Department of Cardiovascular Medicine, Kumamoto University Hospital, Kumamoto,  860-8556,  Japan

Study chairs or principal investigators

Hisao Ogawa, M.D., Ph.D.,  Study Chair,  Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University   

Study ID Numbers:  CVM-RCT-2001-02; KUMSEC-2001-035
Last Updated:  August 8, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00128024
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-08-23