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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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

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Pulmonary Embolism Acute Massive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-immunogenic staphylokinase

Drug: non-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®

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

Intervention Type DRUG

Non-immunogenic staphylokinase 15 mg as a single intravenous bolus

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Fortelyzin®

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 18 years and older.
* Verified diagnosis of massive pulmonary embolism (using computer tomography)
* Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
* The time from the symptoms onset is no more than 14 days.
* Thrombolysis with the non-immunogenic staphylokinase, 15 mg as a single intravenous bolus.

Exclusion Criteria

* Increased risk of bleeding:

* extensive bleeding at present or within the previous 6 months;
* intracranial (including subarachnoid) hemorrhage at present or in history;
* hemorrhagic stroke within the last 6 months;
* a history of diseases of the central nervous system (including neoplasms, aneurysms);
* intracranial or spinal surgical interventions within the last 2 months;
* major surgery or major trauma within the previous 4 weeks;
* recent puncture of an incompressible blood vessel (eg, subclavian or jugular vein);
* severe liver disease, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis;
* confirmed gastric or duodenal ulcer within the last 3 months;
* neoplasm with an increased risk of bleeding;
* simultaneous administration of Dabigatran without prior administration of idarucizumab;
* arterial aneurysms, developmental defects of arteries / veins;
* acute pancreatitis;
* bacterial endocarditis, pericarditis;
* suspicion of aortic dissecting aneurysm;
* any other conditions, in the opinion of the investigator, associated with a high risk of bleeding.
* Lactation, pregnancy.
* Known hypersensitivity to the non-immunogenic recombinant staphylokinase.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No