Study of Half-Dose Recombinant Staphylokinase Before Primary PCI in Patients With ST-Elevation Myocardial Infarction

What this Trial Is About

Researchers are evaluating whether adding a half-dose bolus of recombinant staphylokinase r-SAK, a clot-dissolving drug, immediately before primary percutaneous coronary intervention PCI can improve outcomes in patients with acute ST-segment elevation myocardial infarction STEMI treated within 120 minutes. This randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of r-SAK in reducing major adverse cardiovascular events within 90 days after treatment. Participants are randomly assigned to receive either a single intravenous bolus of 5 mg r-SAK over 3 minutes or a placebo injection within 10 minutes after STEMI diagnosis. Following this, all patients undergo primary PCI within 30 to 120 minutes. The study is conducted across multiple centers and compares the effects of r-SAK versus placebo as adjunctive therapy before PCI. During the study, participants will be monitored for major adverse cardiovascular events up to 90 days, with additional assessments including cardiac and cerebrovascular events, blood biomarkers NT-proBNP, cardiac imaging by echocardiogram and cardiac magnetic resonance imaging CMR, and blood flow in coronary arteries immediately before and after PCI. Safety and efficacy will also be tracked up to one year. The total participation duration includes follow-up visits at days 7, 90, and 360 after treatment.

Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction