NCT07245927

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

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: Supergene, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of FORPE Registry is to study the safety and efficacy of the non-immunogenic staphylokinase in patients with massive pulmonary embolism in routine clinical practice.

Detailed description

In November 2023 a multicenter, open-label, randomized non-inferiority trial of the efficacy and safety of the non-immunogenic staphylokinase (Fortelyzin®) compared with alteplase (Actilyse®) in patients with massive pulmonary embolism (FORPE) has been completed (NCT04688320). FORPE trial is the first report of the non-immunogenic staphylokinase usage in patients with massive pulmonary embolism accompanied by unstable haemodynamics. Non-immunogenic staphylokinase was found to be non-inferior to alteplase (p=1.00). Non-immunogenic staphylokinase had high safety profile and did not cause the major bleeding. No cases of haemorrhagic stroke or major bleeding were recorded in the non-immunogenic staphylokinase group, whereas there were five cases (5%) of BARC type 3+5 bleedings in the alteplase group (p=0.026). All major bleedings and fatal intracranial haemorrhage in the alteplase group were registered only in 60 years old patients. The unique mechanism of action of non-immunogenic staphylokinase allows it to be used in a single dose of 15 mg, regardless of the patient's body weight. Non-immunogenic staphylokinase is easy to administer with a rapid single bolus that makes it convenient for use in emergency medicine. The indication "massive pulmonary embolism" is included in the Instructions for medical use of the non-immunogenic staphylokinase. In routine clinical practice, the non-immunogenic staphylokinase is used for massive pulmonary embolism treatment since 2024. The aim of FORPE Registry is to study the safety and efficacy of the non-immunogenic staphylokinase in patients with massive pulmonary embolism in routine clinical practice.

Conditions

• Pulmonary Embolism Acute Massive

Interventions

Type	Name	Description
DRUG	Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®	Non-immunogenic staphylokinase 15 mg as a single intravenous bolus

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-10-31
• Completion: 2027-12-31
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: Russia