Skip to main content
OpenTrials
Completed

NCT Number: NCT00128024

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiovascular Medicine, Kumamoto University Hospital

Kumamoto, 860-8556, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lipid-lowering treatment

Drug

Primary outcomes

  1. A combination of: 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

  5. and nonfatal stroke

Secondary outcomes

  1. Reintervention procedures: coronary artery bypass grafting (CABG)

  2. percutaneous coronary intervention (PCI) for a new lesion

  3. 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)

Sponsors and collaborators

Lead sponsor

Kumamoto University

Other

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2006
First posted
Aug 9, 2005
Registry last updated
Apr 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.