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

Phase 4

Terminated

• Conditions: Diabetes Mellitus; Myocardial Infarction
• Interventions: Other: control; Drug: pioglitazone

• Registration Number: NCT00212004
• Lead Sponsor: National Cerebral and Cardiovascular Center, Japan

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2017-04
• Study Completion: 2018-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 630

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	control	Participants assigned to Control group were treated with diet and exercise therapy or sulfonylurea (SU) or other additional drugs than pioglitazone.
Pioglitazone	pioglitazone	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All cause mortality	2 years	death of any cause
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
The progression of DM	2 years	HbA1C levels\>7.0%
Hospitalization due to nonfatal myocardial infarction	2 years	nonfatal myocardial infarction
Hospitalization due to cerebral infarction	2 years	cerebral infarction
worsening of renal function	2 years	serum creatine levels\>2.5mg/dL or the increases of serum creatine levels by \>2mg/dL

Trial Locations

Locations (1)

National Cardiovascular Center; 🇯🇵 Suita, Osaka, Japan