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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212004
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cerebral and Cardiovascular Center
  Purpose
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: None (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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

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


Contacts
Contact: Masafumi Kitakaze, MD, PhD 81-6-6833-5012 ext 2225 kitakaze@zf6.so-net.ne.jp
Contact: Jiyoong Kim, MD 81-6-6833-5012 ext 8212 jikim@attglobal.net

Locations
Japan
National Cardiovascular Center Recruiting
Suita, Osaka, Japan, 565-8565
Contact: Masafumi Kitakaze, MD, PhD    81-6-6833-5012 ext 2225    kitakaze@zf6.so-net.ne.jp   
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Investigators
Study Chair: Masafumi Kitakaze, MD, PhD National Cerebral and Cardiovascular Center
  More Information

ClinicalTrials.gov Identifier: NCT00212004     History of Changes
Other Study ID Numbers: CSSCJ-4
UMIN_ID:C000000091
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
Last Verified: November 2004

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

Additional relevant MeSH terms:
Diabetes Mellitus
Infarction
Myocardial Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs