At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Bolus R-SAK Prior to Primary PCI for ST-elevation Myocardial Infarction (OPTIMA-5): 1-Year Follow-up
In Brief
A Phase 4 clinical trial evaluating Recombinant Staphylokinase and Normal Saline for ST-segment Elevation Myocardial Infarction (STEMI). Completed, enrolled 210 participants across 8 sites.
Detailed Summary
The OPTIMA-5 trial is a prospective, multi-center, randomized, patient blinded, controlled trial comparing a single bolus of half-dose recombinant staphylokinase (r-SAK) with normal saline (NS) in patients with ST-segment elevation myocardial infarction (STEMI) presenting ≤12 hours of symptom onset and expected to undergo primary percutaneous coronary intervention (PPCI) within 120 minutes. The results of OPTIMA-5 showed that a single bolus r-SAK prior to PPCI for STEMI improves infarct related artery (IRA) patency and reduces infarct size without increasing major bleeding. On this basis, this study was designed to investigate the effect of the novel reperfusion strategy on 1-year outcomes of patients with STEMI.
Study Details
Timeline
Interventions
Intravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
Intravenous injection of normal saline is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction