A Phase 4 interventional study of pioglitazone and control in Diabetes Mellitus and Myocardial Infarction, sponsored by National Cerebral and Cardiovascular Center, Japan. Terminated at 1 site in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-05-23.
Sponsored by National Cerebral and Cardiovascular Center, Japan · Phase 4, Interventional, and Prevention
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 630 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →National Cerebral and Cardiovascular Center, Japan is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the pioglitazone group were administered a pioglitazone tablet (15 mg) once a day. In the event of the side effects such as oedema, the dosage of pioglitazone was reduced to half or a quarter of the original dosage. Otherwise, we tried to increase the dose of pioglitazone to 30mg/day.
Drug: pioglitazone
Participants assigned to Control group were treated with diet and exercise therapy or sulfonylurea (SU) or other additional drugs than pioglitazone.
Other: control
The time till the first cardiovascular composite endpoint
death from cardiovascular death, and the hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina25, treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft) and cerebral infarction.
Time frame: 2 years
All cause mortality
death of any cause
Time frame: 2 years
Hospitalization due to nonfatal myocardial infarction
nonfatal myocardial infarction
Time frame: 2 years
Hospitalization due to nonfatal unstable angina
nonfatal unstable angina
Time frame: 2 years
Hospitalization due to treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft)
coronary revascularisation
Time frame: 2 years
Hospitalization due to cerebral infarction
cerebral infarction
Time frame: 2 years
The progression of DM
HbA1C levels\>7.0%
Time frame: 2 years
worsening of renal function
serum creatine levels\>2.5mg/dL or the increases of serum creatine levels by \>2mg/dL
Time frame: 2 years
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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National Cerebral and Cardiovascular Center, Japan