Pioglitazone Protects Diabetes Mellitus (DM) Patients Against Re-Infarction (PPAR Study)
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|ClinicalTrials.gov Identifier: NCT00212004|
Recruitment Status : Terminated (Limited budget to continue this study)
First Posted : September 21, 2005
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Myocardial Infarction||Drug: pioglitazone Other: control||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||630 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction|
|Actual Study Start Date :||April 2005|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2018|
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.
Active Comparator: Control
Participants assigned to Control group were treated with diet and exercise therapy or sulfonylurea (SU) or other additional drugs than pioglitazone.
- 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.
- All cause mortality [ Time Frame: 2 years ]death of any cause
- Hospitalization due to nonfatal myocardial infarction [ Time Frame: 2 years ]nonfatal myocardial infarction
- Hospitalization due to nonfatal unstable angina [ Time Frame: 2 years ]nonfatal unstable angina
- Hospitalization due to treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft) [ Time Frame: 2 years ]coronary revascularisation
- Hospitalization due to cerebral infarction [ Time Frame: 2 years ]cerebral infarction
- The progression of DM [ Time Frame: 2 years ]HbA1C levels>7.0%
- worsening of renal function [ Time Frame: 2 years ]serum creatine levels>2.5mg/dL or the increases of serum creatine levels by >2mg/dL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212004
|National Cardiovascular Center|
|Suita, Osaka, Japan, 565-8565|
|Study Chair:||Masafumi Kitakaze, MD, PhD||National Cerebral and Cardiovascular Center|