Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752345
Status:
UNKNOWN
Last Update Posted:
2021-02-12
First Post:
2021-02-09
Brief Title:
Optimal Reperfusion Strategy for STEMI Patients With Anticipated PPCI Delay
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
A Prospective Randomized Multi-center Clinical Trial Comparing Different Fibrinolysis-transfer Percutaneous Coronary Intervention Strategies in Acute ST-segment Elevation Myocardial Infarction
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
NOT_YET_RECRUITING
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:
The OPTIMAL-REPERFUSION trial will help determine whether reduced-dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay
Detailed Description:
OPTIMAL-REPERFUSION is an investigator-initiated prospective multicenter randomized open-label superiority trial with blinded evaluation of outcomes A total of 632 STEMI patients presenting within 6 hours after symptom onset and with an expected time of medical contact to percutaneous coronary intervention 120 min will be randomized to a reduced-dose facilitated PCI strategy reduced-dose fibrinolysis combined with simultaneous transfer for immediate invasive therapy with a time interval between fibrinolysis to PCI 3 hours or to pharmacoinvasive treatment The primary endpoint is the composite of death reinfarction refractory ischemia congestive heart failure or cardiogenic shock at 30-days
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?:
None
Is an FDA AA801 Violation?:
None