Clinical trial NCT00212004: Pioglitazone Protects Diabetes Mellitus (DM) Patients Against Re-Infarction (PPAR Study)
Official title: The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus
Myocardial Infarction
Keywords: diabetes mellitus
myocardial infarction
pioglitazone
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
Collaborators: name: Japan Heart Foundation
First posted: 2005-09-21
Enrollment: 630
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: The time till the first cardiovascular composite endpoint
timeFrame: 2 years
Secondary outcomes:
measure: All cause mortality
timeFrame: 2 years
measure: Hospitalization due to nonfatal myocardial infarction
timeFrame: 2 years
measure: Hospitalization due to nonfatal unstable angina
timeFrame: 2 years
measure: Hospitalization due to treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft)
timeFrame: 2 years
measure: Hospitalization due to cerebral infarction
timeFrame: 2 years
measure: The progression of DM
timeFrame: 2 years
measure: worsening of renal function
timeFrame: 2 years
Other outcomes:
Locations:
city: Suita
country: Japan
facility: National Cardiovascular Center
state: Osaka
Study officials:
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Masafumi Kitakaze, MD, PhD
role: STUDY_CHAIR
References: