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

NCT ID: NCT00212004

Last Updated: 2018-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2018-04-30

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.

Conditions

Diabetes Mellitus; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

pioglitazone

Intervention Type: DRUG

Control

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

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: OTHER

Interventions

pioglitazone

Intervention Type: DRUG

control

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japan Heart Foundation

OTHER

Sponsor Role: collaborator

National Cerebral and Cardiovascular Center, Japan

OTHER

Sponsor Role: lead

Responsible Party

Masafumi Kitakaze

Department of Clinical Medicine and Development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Masafumi Kitakaze, MD, PhD

Role: STUDY_CHAIR

National Cerebral and Cardiovascular Center, Japan

Locations

National Cardiovascular Center

Suita, Osaka, Japan

Countries

Japan

Other Identifiers

UMIN_ID:C000000091

Identifier Type: -

Identifier Source: secondary_id

Umin Center

Identifier Type: OTHER

Identifier Source: secondary_id

CSSCJ-4

Identifier Type: -

Identifier Source: org_study_id