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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2004 by National Cerebral and Cardiovascular Center.
Recruitment status was:  Recruiting
Information provided by:
National Cerebral and Cardiovascular Center Identifier:
First received: September 13, 2005
Last updated: NA
Last verified: November 2004
History: No changes posted
To evaluate whether the pioglitazone could reduce the recurrence of myocardial infarction in patients with DM and old myocardial infarction

Condition Intervention
Diabetes Mellitus
Myocardial Infarction
Drug: pioglitazone
Drug: sulfonylurea agents

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction

Resource links provided by NLM:

Further study details as provided by National Cerebral and Cardiovascular Center:

Primary Outcome Measures:
  • 1.Cardiovascular mortality
  • 2.Hospitalization due to cardiovascular events

Secondary Outcome Measures:
  • (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

Estimated Enrollment: 3000
Study Start Date: April 2005
Estimated Study Completion Date: April 2009
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.

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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. diabetes mellitus (HbA1c < 6.5%)
  2. History of myocardial infarction

Exclusion Criteria:

  1. Symptomatic CHF
  2. Type I diabetes
  3. History of coronary artery bypass graft
  4. Severe liver and/or kidney dysfunction
  5. History of allergic response to drugs
  6. arteriosclerosis obliterans
  Contacts and Locations
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Please refer to this study by its identifier: NCT00212004

National Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Study Chair: Masafumi Kitakaze, MD, PhD National Cerebral and Cardiovascular Center
  More Information Identifier: NCT00212004     History of Changes
Other Study ID Numbers: CSSCJ-4  UMIN_ID:C000000091 
Study First Received: September 13, 2005
Last Updated: September 13, 2005

Keywords provided by National Cerebral and Cardiovascular Center:
diabetes mellitus
myocardial infarction

Additional relevant MeSH terms:
Diabetes Mellitus
Myocardial Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on February 20, 2017