ArticleHealth science reports2025
The Safety of Non-immunogenic Recombinant Staphylokinase in Elderly Patients With Massive Pulmonary Embolism: A Randomized Clinical Trial FORPE.
Article in Health science reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Multicenter, Double-blind, Randomized, Placebo-controlled Trial of the Efficacy and Safety of a Single Bolus Administration of Non-immunogenic Recombinant Staphylokinase in Patients With Intermediate High-risk Pulmonary Embolism (FORPE-2)
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)
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Authors and funding
10 authors.
Funding
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Abstract
Background and Aims: Major bleedings are the most limiting factor of the usage of thrombolytic agents in pulmonary embolism (PE), especially in elderly patients. Non-immunogenic staphylokinase is a recombinant staphylokinase with high thrombolytic activity, fibrin selectivity, and low immunogenic properties. We performed a post hoc analysis of safety outcomes in elderly patients with massive PE over 60 years' old who received non-immunogenic staphylokinase in FORPE trial. Methods: A randomized, open-label, multicenter, parallel-group, noninferiority FORPE trial was conducted at 23 clinical sites in Russia. A total of 310 patients aged 18 years and older with massive PE proven by computed tomography pulmonary angiography, right ventricular dysfunction, and hemodynamic instability were included. The patients were randomized for treatment either the non-immunogenic staphylokinase (15 mg) or alteplase (100 mg). Safety outcomes were hemorrhagic stroke, bleeding types 3 and 5 according to BARC classification within 7 days after randomization. Results: No cases of hemorrhagic stroke or major bleeding were registered in the non-immunogenic staphylokinase group, whereas there were five incidences (5%) of BARC type 3 + 5 bleedings in the alteplase group ( Conclusion: The FORPE trial showed that the treatment of massive PE with hemodynamic instability with the non-immunogenic staphylokinase was safe in elderly patients over 60 years and can be used in emergency medicine in the real-world clinical practice. Future trials and PE registries are needed to make a final decision on safety of thrombolytic therapy with the non-immunogenic staphylokinase in elderly patients.
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Registered trials
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