Status:
TERMINATED
Pioglitazone Protects Diabetes Mellitus (DM) Patients Against Re-Infarction (PPAR Study)
Lead Sponsor:
National Cerebral and Cardiovascular Center, Japan
Collaborating Sponsors:
Japan Heart Foundation
Conditions:
Diabetes Mellitus
Myocardial Infarction
Eligibility:
All Genders
20-79 years
Phase:
PHASE4
Brief Summary
To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (MI) in patients with DM and old myocardial infarction
Detailed Description
Type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in coronary artery. So we designed a prospective randomized multi-center trial named th...
Eligibility Criteria
Inclusion
- diabetes mellitus (fasting plasma glucose levels of\>126 mg/dL, or 2-hour 75g oral glucose tolerance test (OGTT) value of \>200 mg/dL, and HbA1c levels of\<6.5% (47.5 IFCC))
- History of myocardial infarction
- Age between 20-79 years old
Exclusion
- acute MI occurring within the last 7 days
- New York Heart Association (NYHA) symptoms of no fewer II or with left ventricular ejection fraction of not more than 40%
- suspected type I DM
- scheduled coronary angioplasty or history of coronary artery bypass graft surgery
- serious liver or kidney damage
- history of allergy or drug hypersensitivity
- arteriosclerosis obliterans with Fontaine stage III or worse
- inability to understand and/or comply with study medications, procedures and/or follow-up or any conditions that may render the patient unable to complete the study in the opinion of the investigator.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00212004
Start Date
April 1 2005
End Date
April 1 2018
Last Update
May 23 2018
Active Locations (1)
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1
National Cardiovascular Center
Suita, Osaka, Japan, 565-8565