Efficacy and safety of a bolus of half-dose recombinant staphylokinase (r-SAK) prior to primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction: Rationale and design of the OPTIMA-6 trial
Study context
- Population
- Acute ST-elevation myocardial infarction (STEMI) ≤12 h from symptom onset, expected primary PCI within 120 min but >30 min; all on aspirin, ticagrelor and loading-dose heparinplanned enrolment
- Participants
- 2,260 participants
- Planned comparison
- Half-dose r-SAK bolus vs placebo before primary PCI
- Primary endpoint
- Major adverse cardiovascular events (MACE):
- All-cause death
- Reinfarction
- Unplanned target vessel revascularization
- HF or cardiogenic shock
- Major ventricular arrhythmia
- Follow-up
- 90 days
Methodological detailsmulticentre, double-blind, placebo-controlled, superiority, Enrolment began April 2023; ≈50 centres, Primary safety endpoint: major bleeding (BARC 3, 5) within 90 days
- Multicentre
- Double-blind
- Placebo-controlled
- Superiority
- Enrolment began April 2023; ≈50 centres
- Primary safety endpoint: major bleeding (BARC 3, 5) within 90 days
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Efficacy and safety of a bolus of half-dose r-SAK prior to primary PCI in ST-elevation myocardial infarction: Rationale and design of the OPTIMA-6 trial. Am Heart J. Published 25 June 2023. doi:10.
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