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
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: lipid-lowering treatment
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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)

Enrollment: 460
Study Start Date: February 2002
Study Completion Date: February 2006
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Statins Drug: lipid-lowering treatment
No Intervention: No statins

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00128024

Locations
Japan
Department of Cardiovascular Medicine, Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
Investigators
Study Chair: Hisao Ogawa, M.D., Ph.D. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
  More Information

No publications provided

Responsible Party: Hisao Ogawa, Pofessor, Kumamoto University
ClinicalTrials.gov Identifier: NCT00128024     History of Changes
Other Study ID Numbers: CVM-RCT-2001-02, KUMSEC-2001-035
Study First Received: August 8, 2005
Last Updated: April 17, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kumamoto University:
randomized prospective study
lipid-lowering therapy with any available statins
multicenter study
Japanese
acute myocardial infarction
primary percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014