An Open, Prospective, Non-interventional, Multicentre, Controlled Study of Safety and Efficacy of the Thrombolysis With the Non-immunogenic Staphylokinase in Patients With Massive Pulmonary Embolism (FORPE Registry)

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a non-immunogenic staphylokinase called Fortelyzin® in patients with massive pulmonary embolism, a serious condition where blood clots block the lungs. This study follows up on a previous trial that showed this treatment was as effective as alteplase but with fewer major bleeding events, especially in older patients. The study aims to observe how this treatment works in routine clinical practice starting from 2024. The treatment involves a single intravenous bolus dose of 15 mg of non-immunogenic staphylokinase, regardless of the patient's body weight. This easy-to-administer dose is designed for emergency use. The study is observational and non-interventional, meaning patients receive this treatment as part of their standard care while researchers collect data on its safety and results. Participants are monitored for outcomes including all-cause mortality at 7 and 30 days after treatment, signs of haemodynamic collapse, recurrent pulmonary embolism, and pulmonary artery systolic pressure before and two days after treatment. The study collects this data across multiple centers and continues until the end of 2027. Safety and efficacy data gathered will help understand how this drug performs outside of controlled trials in real-world settings.

Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism