Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212030
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2005-09-13
Brief Title:
Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Sponsor:
National Cerebral and Cardiovascular Center Japan
Organization:
National Cerebral and Cardiovascular Center Japan
Study Overview
Official Title:
Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion
Detailed Description:
The benefits of percutaneous coronary intervention PCI in acute myocardial infarction AMI are limited by reperfusion injury In animal models nicorandil a hybrid of an ATP-sensitive K KATP channel opener and nitrates reduces infarct size so the Japan-Working groups of acute myocardial Infarction for the reduction of Necrotic Damage by a K-ATP channel opener J-WIND-KATP designed a prospective randomized multicenter study to evaluate whether nicorandil reduces myocardial infarct size and improves regional wall motion when used as an adjunctive therapy for AMI
Twenty-six hospitals in Japan are participating in the J-WIND-KATP study Patients with AMI who are candidates for PCI are randomly allocated to receive either intravenous nicorandil or placebo The primary end-points are 1 estimated infarct size and 2 left ventricular function Single nucleotide polymorphisms SNPs that may be associated with the function of KATP-channel and the susceptibility of AMI to the drug will be examined Furthermore a data mining method will be used to design the optimal combined therapy for post-myocardial infarction MI patients
It is intended that J-WIND-KATP will provide important data on the effects of nicorandil as an adjunct to PCI for AMI and that the SNPs information that will open the field of tailor-made therapy The optimal therapeutic drug combination will also be determined for post-MI patients
Twenty-six hospitals in Japan are participating in the J-WIND-KATP study Patients with AMI who are candidates for PCI are randomly allocated to receive either intravenous nicorandil or placebo The primary end-points are 1 estimated infarct size and 2 left ventricular function Single nucleotide polymorphisms SNPs that may be associated with the function of KATP-channel and the susceptibility of AMI to the drug will be examined Furthermore a data mining method will be used to design the optimal combined therapy for post-myocardial infarction MI patients
It is intended that J-WIND-KATP will provide important data on the effects of nicorandil as an adjunct to PCI for AMI and that the SNPs information that will open the field of tailor-made therapy The optimal therapeutic drug combination will also be determined for post-MI patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMIN_IDC000000089 | None | None | None |