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Recruiting NCT07245927

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

— Observational Pulmonary Embolism Acute Massive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®.
Who it may be relevant to
Registry conditions: Pulmonary Embolism Acute Massive. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

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.

Detailed 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.

Interventions

  • Drug 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

Primary outcome measures

  • All-cause mortality [Time frame: day 7 after drug administration]
Secondary outcome measures (4)
  • All-cause mortality [Time frame: day 30 after drug administration]
  • Haemodynamic Collapse [Time frame: day 30 after drug administration]
  • Recurrent Pulmonary Embolism [Time frame: day 30 after drug administration]
  • Pulmonary Artery Systolic Pressure Measures [Time frame: baseline and day 2 after drug administration]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Russia · 14 centers
  • 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
  • … and 6 more centers

Publications

  • 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

Identifiers

NCT: NCT07245927 · FORPE Registry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗