Study of Single Dose Non-immunogenic Recombinant Staphylokinase Compared to Placebo for Treating Intermediate High-risk Pulmonary Embolism in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a single bolus dose of non-immunogenic recombinant staphylokinase compared to a placebo in adults with intermediate high-risk pulmonary embolism PE who have stable blood pressure. This phase 3 trial addresses the need for safer thrombolytic treatments in patients who are at risk but do not have shock or low blood pressure, as previous thrombolytics had risks like hemorrhagic stroke. The study aims to improve outcomes while minimizing adverse effects in this patient group. Participants receive either a quick intravenous injection of non-immunogenic recombinant staphylokinase or a matching placebo. The staphylokinase dose is 15 mg given as a single bolus over 10-15 seconds regardless of body weight. The placebo group receives a similar injection with saline solution. This treatment period is followed by monitoring to compare the effects and safety between the two groups. During the study, participants will be assessed for clinical outcomes including death, hemodynamic collapse, and recurrent pulmonary embolism within 30 days. Additional measures include heart function and lung pressure evaluations within 24 hours and 30 days, along with monitoring for bleeding events and other adverse effects. The trial lasts for 30 days after treatment with ongoing safety checks, and participant consent and adherence to contraceptive use are required throughout the study period.

Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism