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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
Sponsor:
Collaborator:
Japan Heart Foundation
Information provided by (Responsible Party):
Masafumi Kitakaze, National Cerebral and Cardiovascular Center

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Myocardial Infarction Drug: pioglitazone Other: control Phase 4

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.

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
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
Actual Study Start Date : April 2005
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: pioglitazone
Active Comparator: Control
Participants assigned to Control group were treated with diet and exercise therapy or sulfonylurea (SU) or other additional drugs than pioglitazone.
Other: control



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 2 years ]
    death of any cause

  2. Hospitalization due to nonfatal myocardial infarction [ Time Frame: 2 years ]
    nonfatal myocardial infarction

  3. Hospitalization due to nonfatal unstable angina [ Time Frame: 2 years ]
    nonfatal unstable angina

  4. Hospitalization due to treatment with coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft) [ Time Frame: 2 years ]
    coronary revascularisation

  5. Hospitalization due to cerebral infarction [ Time Frame: 2 years ]
    cerebral infarction

  6. The progression of DM [ Time Frame: 2 years ]
    HbA1C levels>7.0%

  7. worsening of renal function [ Time Frame: 2 years ]
    serum creatine levels>2.5mg/dL or the increases of serum creatine levels by >2mg/dL



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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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


Locations
Japan
National Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Japan Heart Foundation
Investigators
Study Chair: Masafumi Kitakaze, MD, PhD National Cerebral and Cardiovascular Center

Responsible Party: Masafumi Kitakaze, Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier: NCT00212004     History of Changes
Other Study ID Numbers: CSSCJ-4
UMIN_ID:C000000091
Umin Center ( Other Identifier: Japanese government )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Masafumi Kitakaze, 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