NCT00128024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

August 8, 2005

Last Update Submit

April 17, 2013

Conditions

Myocardial Infarction

Keywords

randomized prospective studylipid-lowering therapy with any available statinsmulticenter studyJapaneseacute myocardial infarctionprimary percutaneous coronary intervention

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • 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)

Study Arms (2)

Statins

ACTIVE COMPARATOR
Drug: lipid-lowering treatment

No statins

NO INTERVENTION

Interventions

lipid-lowering treatmentDRUG
Statins

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of acute myocardial infarction
  • Serum total cholesterol levels on admission ranges ≥180 mg/dL and \<240 mg/dL

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Medicine, Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Hisao Ogawa, M.D., Ph.D.

    Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pofessor

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

February 1, 2002

Primary Completion

February 1, 2004

Study Completion

February 1, 2006

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations

JP(1)