NCT04752345

Optimal Reperfusion Strategy for STEMI Patients With Anticipated PPCI Delay

A Prospective Randomized Multi-center Clinical Trial Comparing Different Fibrinolysis-transfer Percutaneous Coronary Intervention Strategies in Acute ST-segment Elevation Myocardial Infarction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 632 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
OTHER	Pharmacoinvasive strategy	Pharmacoinvasive treatment \[full-dose fibrinolysis combined with rescue PCI (in case of failed fibrinolysis) or routine early PCI (3 to 24 hours, in case of successful fibrinolysis)
OTHER	Reduced-dose facilitated PCI strategy	Reduced-dose facilitated PCI\[reduced-dose fibrinolysis,simultaneously transfer,immediate coronary angiography and andioplasty when arrived at PCI center(\<3 hours)\]

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2021-02-12
• Last updated: 2021-02-12