Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212004
Status:
TERMINATED
Last Update Posted:
2018-05-23
First Post:
2005-09-13
Brief Title:
Pioglitazone Protects Diabetes Mellitus DM Patients Against Re-Infarction PPAR Study
Sponsor:
National Cerebral and Cardiovascular Center Japan
Organization:
National Cerebral and Cardiovascular Center Japan
Study Overview
Official Title:
The Japan Working Group for the Assessment That the Pioglitazone Protects DM Patients Against Re-Infarction
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Limited budget to continue this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infarctionPPAR study to evaluate whether pioglitazone could reduce the recurrence of myocardial infarction in patients with DMHbA1c65 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 1instructs weight reduction appropriate diet regular exercise andor 2prescribes 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
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 1instructs weight reduction appropriate diet regular exercise andor 2prescribes 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Umin Center | OTHER | Japanese government | None |
| UMIN_IDC000000091 | None | None | None |