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

Supergene, LLC20,000 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

20,000

Conditions

Pulmonary Embolism Acute Massive

Interventions

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

Non-immunogenic staphylokinase 15 mg as a single intravenous bolus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

E.I. Chazov National Medical Research Center of Cardiology

Moscow, Russia

RECRUITING

Outcomes

Primary Outcomes

All-cause mortality

The number of death from any causes during admission

Time frame: day 7 after drug administration

Secondary Outcomes

All-cause mortality

The number of death from any causes during 30 days after drug administration

Time frame: day 30 after drug administration

Haemodynamic Collapse

The number of haemodynamic collapses from any causes during 30 days after drug administration

Time frame: day 30 after drug administration

Recurrent Pulmonary Embolism

The number of recurrent pulmonary embolism from any causes during 30 days after drug administration

Time frame: day 30 after drug administration

Pulmonary Artery Systolic Pressure Measures

The efficacy is evaluated in terms of pulmonary artery systolic pressure after drug administration

Time frame: baseline and day 2 after drug administration

Central Contacts

Sergei S. Markin, MD, Prof.

CONTACT

(495) 287-98-07 ssmarkin2153@mail.ru

Data from ClinicalTrials.gov

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