NCT00212004

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

The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 630 (actual)
• Sponsor: National Cerebral and Cardiovascular Center, Japan · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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 the pioglitazone could reduce the recurrence of myocardial infarction in patients with DM and myocardial infarction(PPAR study) to evaluate whether pioglitazone could reduce the recurrence of myocardial infarction in patients with DM(HbA1c\<6.5%) and myocardial infarction. More than 100 hospitals will participate in the PPAR study. Patients with DM who have history of prior myocardial infarction are randomly allocated to receive pioglitazone or (1)instructs weight reduction, appropriate diet, regular exercise and/or (2)prescribes sulfonylurea agents. The number of patients to be recruited is 720 and this study will continue at least 2 years until 7 year or the end of the study. The primary end-points are (1) cardiovascular mortality and (2) hospitalization for cardiovascular events. Effects in suppression of new diabetes development also will be evaluated. We should recognize DM as important therapeutic target to decrease recurrence of cardiovascular events. PPAR study, a large scale multi-center trial in Japan, will provide us new evidence how to treat DM patients with prior myocardial infarction.

Conditions

• Diabetes Mellitus
• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	pioglitazone
OTHER	control

Timeline

• Start date: 2005-04-01
• Primary completion: 2017-04-01
• Completion: 2018-04-01
• First posted: 2005-09-21
• Last updated: 2018-05-23

Locations

1 site across 1 country: Japan