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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• All-cause mortality [Срок оценки: day 7 after drug administration]

Вторичные конечные точки (4)

• All-cause mortality [Срок оценки: day 30 after drug administration]
• Haemodynamic Collapse [Срок оценки: day 30 after drug administration]
• Recurrent Pulmonary Embolism [Срок оценки: day 30 after drug administration]
• Pulmonary Artery Systolic Pressure Measures [Срок оценки: baseline and day 2 after drug administration]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Россия · 14 центров

• Belgorod Regional Clinical Hospital of St. Joseph — Belgorod
• Kuzbass Cardiology center — Kemerovo
• Center of Neurology and Cardiology — Kirov
• Lipetsk City Hospital No. 4 "Lipetsk-Med" — Lipetsk
• E.I. Chazov National Medical Research Center of Cardiology — Moscow
• F.I. Inozemtsev City Clinical Hospital — Moscow
• Moscow Multidisciplinary Clinical Center "Kommunarka" — Moscow
• S.P. Botkin City Clinical Hospital — Moscow
• … и ещё 6 центров

Публикации

• Kirienko AI, Leontyev SG, Tereschenko SN, Yavelov IS, Shakhnovich RM, Erlikh AD, Talibov OB, Yarovaya EB, Semenov AM, Semenov MP, Ivanov SV, Beregovykh VV, Archakov AI, Markin SS; FORPE study group. Non-immunogenic recombinant staphylokinase versus alteplase for patients with massive pulmonary embolism: a randomized open-label, multicenter, parallel-group, non-inferiority trial, FORPE. J Thromb Ha PMID 39454884
• Leontyev SG, Yarovaya EB, Kutsenko VA, Ivlev OE, Soplenkova AG, Semenov AM, Semenov MP, Ivanov SV, Romashova YA, Markin SS. The Safety of Non-immunogenic Recombinant Staphylokinase in Elderly Patients With Massive Pulmonary Embolism: A Randomized Clinical Trial FORPE. Health Sci Rep. 2025 May 19;8(5):e70826. doi: 10.1002/hsr2.70826. eCollection 2025 May. PMID 40391253

Идентификаторы

NCT: NCT07245927 · FORPE Registry

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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