Pioglitazone Protects Diabetes Mellitus (DM) Patients Against Re-Infarction (PPAR Study)

• Status: Terminated
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (MI) in patients with DM and old myocardial infarction

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cerebral and Cardiovascular Center
• Collaborator: Japan Heart Foundation
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

1. 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))

2. History of myocardial infarction

3. Age between 20-79 years old

Exclusion Criteria:

1. acute MI occurring within the last 7 days

2. New York Heart Association (NYHA) symptoms of no fewer II or with left ventricular ejection fraction of not more than 40%

3. suspected type I DM

4. scheduled coronary angioplasty or history of coronary artery bypass graft surgery

5. serious liver or kidney damage

6. history of allergy or drug hypersensitivity

7. arteriosclerosis obliterans with Fontaine stage III or worse

8. 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.