Pioglitazone Protects Diabetes Mellitus (DM) Patients Aga... | NCT00212004

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

NCT00212004

Sponsor

National Cerebral and Cardiovascular Center, Japan

Status

Terminated

Last Update Posted

May 23, 2018Actual

Enrollment

630Actual

Phase

Phase 4

Conditions

Diabetes Mellitus
Myocardial Infarction

Interventions

pioglitazone
control

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UMIN_ID:C000000091
Umin Center	Other Identifier	Japanese government

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Limited budget to continue this study

Expanded Access Info

Start Date

Apr 2005Actual

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2018Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2018

Last Update Posted Date

May 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Masafumi Kitakaze, Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, JapanPrincipal Investigator

Lead Sponsor

National Cerebral and Cardiovascular Center, JapanOTHER

Collaborators

Name	Class
Japan Heart Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

630Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pioglitazone	Active Comparator	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
Control	Active Comparator	Participants assigned to Control group were treated with diet and exercise therapy or sulfonylurea (SU) or other additional drugs than pioglitazone.	Other: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pioglitazone	Drug		Pioglitazone
control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The time till the first cardiovascular composite endpoint	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.	2 years

Secondary Outcomes

Measure	Description	Time Frame
All cause mortality	death of any cause	2 years
Hospitalization due to nonfatal myocardial infarction	nonfatal myocardial infarction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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))
History of myocardial infarction
Age between 20-79 years old

Exclusion Criteria:

acute MI occurring within the last 7 days
New York Heart Association (NYHA) symptoms of no fewer II or with left ventricular ejection fraction of not more than 40%
suspected type I DM
scheduled coronary angioplasty or history of coronary artery bypass graft surgery
serious liver or kidney damage
history of allergy or drug hypersensitivity
arteriosclerosis obliterans with Fontaine stage III or worse
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Masafumi Kitakaze, MD, PhD	National Cerebral and Cardiovascular Center, Japan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cardiovascular Center		Suita	Osaka	565-8565	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077205	Pioglitazone

Ancestor Terms

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided