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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hisao Ogawa, Kumamoto University
ClinicalTrials.gov Identifier:
NCT00128024
First received: August 8, 2005
Last updated: April 17, 2013
Last verified: April 2013

August 8, 2005
April 17, 2013
February 2002
February 2004   (final data collection date for primary outcome measure)
  • 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
  • A combination of:
  • (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.
  • (1)cardiovascular death,
Complete list of historical versions of study NCT00128024 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
Not Provided
Not Provided
 
Effects of Early Statin Treatment After Acute Myocardial Infarction (AMI) in Japanese Patients
Effects of Early Statin Treatment on Symptomatic Heart Failure and Ischemic Events After Acute Myocardial Infarction. The MUSASHI-AMI: A Multicenter Randomized Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Myocardial Infarction
Drug: lipid-lowering treatment
  • Active Comparator: Statins
    Intervention: Drug: lipid-lowering treatment
  • No Intervention: No statins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
February 2006
February 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00128024
CVM-RCT-2001-02, KUMSEC-2001-035
Not Provided
Hisao Ogawa, Kumamoto University
Kumamoto University
Not Provided
Study Chair: Hisao Ogawa, M.D., Ph.D. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP