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

May 22, 2018 updated by: Masafumi Kitakaze, National Cerebral and Cardiovascular Center

The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction

To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction (MI) in patients with DM and old myocardial infarction

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

630

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 565-8565
        • National Cardiovascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: pioglitazone
Active Comparator: Control
Participants assigned to Control group were treated with diet and exercise therapy or sulfonylurea (SU) or other additional drugs than pioglitazone.
Other: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time till the first cardiovascular composite endpoint
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 2 years
death of any cause
2 years
Hospitalization due to nonfatal myocardial infarction
Time Frame: 2 years
nonfatal myocardial infarction
2 years
Hospitalization due to nonfatal unstable angina
Time Frame: 2 years
nonfatal unstable angina
2 years
Hospitalization due to treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft)
Time Frame: 2 years
coronary revascularisation
2 years
Hospitalization due to cerebral infarction
Time Frame: 2 years
cerebral infarction
2 years
The progression of DM
Time Frame: 2 years
HbA1C levels>7.0%
2 years
worsening of renal function
Time Frame: 2 years
serum creatine levels>2.5mg/dL or the increases of serum creatine levels by >2mg/dL
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cerebral and Cardiovascular Center

Collaborators

Japan Heart Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2005

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSSCJ-4
  • UMIN_ID:C000000091
  • Umin Center (Other Identifier: Japanese government)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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