Pioglitazone Protects DM Patients Against Re-Infarction (PPAR Study)
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|ClinicalTrials.gov Identifier: NCT00212004|
Recruitment Status : Unknown
Verified November 2004 by National Cerebral and Cardiovascular Center.
Recruitment status was: Recruiting
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus Myocardial Infarction||Drug: pioglitazone Drug: sulfonylurea agents|
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.
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 3000 and this study will continue at least 2 years. 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)|
|Estimated Enrollment :||3000 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|
|Study Start Date :||April 2005|
|Estimated Study Completion Date :||April 2009|
- 1.Cardiovascular mortality
- 2.Hospitalization due to cardiovascular events
- (1) All cause mortality
- (2) Hospitalization due to coronary artery disease
- (3) Progression of IGT to diabetes
- (4) Development or deterioration of either hypertension or hyperlipidemia
- (5) Deterioraion of renal function
- (6) Hospitalization due to cerebrovascular disease
- (7) Hospitalization due to heart failure
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
|Contact: Masafumi Kitakaze, MD, PhD||81-6-6833-5012 ext firstname.lastname@example.org|
|Contact: Jiyoong Kim, MD||81-6-6833-5012 ext email@example.com|
|National Cardiovascular Center||Recruiting|
|Suita, Osaka, Japan, 565-8565|
|Contact: Masafumi Kitakaze, MD, PhD 81-6-6833-5012 ext 2225 firstname.lastname@example.org|
|Study Chair:||Masafumi Kitakaze, MD, PhD||National Cerebral and Cardiovascular Center|