Clinical trial NCT00128024: Effects of Early Statin Treatment After Acute Myocardial Infarction (AMI) in Japanese Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: randomized prospective study
lipid-lowering therapy with any available statins
multicenter study
Japanese
acute myocardial infarction
primary percutaneous coronary intervention
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2005-08-09
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: A combination of: cardiovascular death
measure: nonfatal acute myocardial infarction
measure: recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization
measure: congestive heart failure requiring emergent rehospitalization
measure: and nonfatal stroke
Secondary outcomes:
measure: Reintervention procedures: coronary artery bypass grafting (CABG)
measure: percutaneous coronary intervention (PCI) for a new lesion
measure: 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)
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Department of Cardiovascular Medicine, Kumamoto University Hospital
Study officials:
affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
name: Hisao Ogawa, M.D., Ph.D.
role: STUDY_CHAIR
References: