Diabetes Mellitus Clinical Trial
Official title:
The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction
To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (MI) in patients with DM and old myocardial infarction
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.
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