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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
lipid-lowering treatment
Sponsored by
Kumamoto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring randomized prospective study, lipid-lowering therapy with any available statins, multicenter study, Japanese, acute myocardial infarction, primary percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Cardiovascular Medicine, Kumamoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Statins

No statins

Arm Description

Outcomes

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)

Full Information

First Posted
August 8, 2005
Last Updated
April 17, 2013
Sponsor
Kumamoto University
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1. Study Identification

Unique Protocol Identification Number
NCT00128024
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kumamoto University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
randomized prospective study, lipid-lowering therapy with any available statins, multicenter study, Japanese, acute myocardial infarction, primary percutaneous coronary intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Statins
Arm Type
Active Comparator
Arm Title
No statins
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
lipid-lowering treatment
Primary Outcome Measure Information:
Title
A combination of: cardiovascular death
Title
nonfatal acute myocardial infarction
Title
recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization
Title
congestive heart failure requiring emergent rehospitalization
Title
and nonfatal stroke
Secondary Outcome Measure Information:
Title
Reintervention procedures: coronary artery bypass grafting (CABG)
Title
percutaneous coronary intervention (PCI) for a new lesion
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisao Ogawa, M.D., Ph.D.
Organizational Affiliation
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiovascular Medicine, Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan

12. IPD Sharing Statement

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

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