Overview
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.
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.
Eligibility
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.