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

NCT07245927 | Recruiting

• 1 other identifier: FORPE Registry
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism Acute Massive

Keywords

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  The number of death from any causes during admission

  day 7 after drug administration

Secondary Outcomes (4)

• All-cause mortality

  day 30 after drug administration

• Haemodynamic Collapse

  day 30 after drug administration

• Recurrent Pulmonary Embolism

  day 30 after drug administration

• Pulmonary Artery Systolic Pressure Measures

  baseline and day 2 after drug administration

Other Outcomes (2)

• Intracranial haemorrhage

  day 30 after drug administration

• Major bleedings

  day 30 after drug administration

Study Arms (1)

Non-immunogenic staphylokinase

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

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

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

Also known as: Fortelyzin®

Non-immunogenic staphylokinase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women aged 18 years and older with verified massive pulmonary embolism, who received a single intravenous bolus of the non-immunogenic staphylokinase (15 mg).

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Supergene, LLC: lead
• National Medical Research Center for Cardiology, Ministry of Health of Russian Federation: collaborator

Study Sites (1)

E.I. Chazov National Medical Research Center of Cardiology

Moscow, 121552, Russia

RECRUITING

Related Publications (2)

• 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 Haemost. 2025 Feb;23(2):657-667. doi: 10.1016/j.jtha.2024.09.035. Epub 2024 Oct 23.

  PMID: 39454884 RESULT

• 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 RESULT

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sergei S. Markin, MD, Prof.

  LLC "SuperGene"

  STUDY DIRECTOR

Central Study Contacts

Sergei S. Markin, MD, Prof.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)