Diabetes Mellitus, Myocardial Infarction
Conditions
Keywords
diabetes mellitus, myocardial infarction, pioglitazone
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 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.
Interventions
DRUGpioglitazone
OTHERcontrol
Sponsors
Japan Heart Foundation
National Cerebral and Cardiovascular Center, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time till the first cardiovascular composite endpoint | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization due to nonfatal myocardial infarction | 2 years | nonfatal myocardial infarction |
| Hospitalization due to nonfatal unstable angina | 2 years | nonfatal unstable angina |
| Hospitalization due to treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft) | 2 years | coronary revascularisation |
| All cause mortality | 2 years | death of any cause |
| The progression of DM | 2 years | HbA1C levels\>7.0% |
| worsening of renal function | 2 years | serum creatine levels\>2.5mg/dL or the increases of serum creatine levels by \>2mg/dL |
| Hospitalization due to cerebral infarction | 2 years | cerebral infarction |
Countries
Japan
Outcome results
None listed