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

SuperGene

Status

Enrolling

Conditions

Pulmonary Embolism Acute Massive

Treatments

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

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07245927

FORPE Registry

Details and patient eligibility

About

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.

Full 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.

Enrollment

20,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.