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

November 17, 2025 updated by: Supergene, LLC

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
      • Moscow, Russia, 121552
        • Recruiting
        • E.I. Chazov National Medical Research Center of Cardiology
        • Contact:
        • Principal Investigator:
          • Sergey N. Tereschenko, MD, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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®
Non-immunogenic staphylokinase 15 mg as a single intravenous bolus
Other Names:
  • Fortelyzin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: day 7 after drug administration
The number of death from any causes during admission
day 7 after drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: day 30 after drug administration
The number of death from any causes during 30 days after drug administration
day 30 after drug administration
Haemodynamic Collapse
Time Frame: day 30 after drug administration
The number of haemodynamic collapses from any causes during 30 days after drug administration
day 30 after drug administration
Recurrent Pulmonary Embolism
Time Frame: day 30 after drug administration
The number of recurrent pulmonary embolism from any causes during 30 days after drug administration
day 30 after drug administration
Pulmonary Artery Systolic Pressure Measures
Time Frame: baseline and day 2 after drug administration
The efficacy is evaluated in terms of pulmonary artery systolic pressure after drug administration
baseline and day 2 after drug administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial haemorrhage
Time Frame: day 30 after drug administration
The number of intracranial haemorrhage during 30 days after drug administration
day 30 after drug administration
Major bleedings
Time Frame: day 30 after drug administration
The number of major bleedings (according to BARC classification type 3 and 5) during 30 days after drug administration
day 30 after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supergene, LLC

Collaborators

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Investigators

  • Study Director: Sergei S. Markin, MD, Prof., LLC "SuperGene"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FORPE Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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