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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00212004
• Other study ID #: CSSCJ-4
• Secondary ID: UMIN_ID:C0000000
• Status: Terminated
• Phase: Phase 4
• Start date: April 2005
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: National Cerebral and Cardiovascular Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 630
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Infarction
• Myocardial Infarction

Intervention

Drug:
• pioglitazone

Other:
• control

Locations

Country	Name	City	State
Japan	National Cardiovascular Center	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center	Japan Heart Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time till the first cardiovascular composite endpoint	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	All cause mortality	death of any cause	2 years
Secondary	Hospitalization due to nonfatal myocardial infarction	nonfatal myocardial infarction	2 years
Secondary	Hospitalization due to nonfatal unstable angina	nonfatal unstable angina	2 years
Secondary	Hospitalization due to treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft)	coronary revascularisation	2 years
Secondary	Hospitalization due to cerebral infarction	cerebral infarction	2 years
Secondary	The progression of DM	HbA1C levels>7.0%	2 years
Secondary	worsening of renal function	serum creatine levels>2.5mg/dL or the increases of serum creatine levels by >2mg/dL	2 years