Pulmonary Embolism Acute MassiveNCT07245927
Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism
An observational study of Pulmonary Embolism Acute Massive, run by Supergene, LLC at 14 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism Acute Massive
- What is being tested?
- Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®
- Type of treatment
- Injection or infusion
- How many people
- 20,000 participants
- Where
- 14 sitesRussia
- Study dates
- 1 Jun 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Russia14 sites, 14 recruiting
- Recruiting
Belgorod Regional Clinical Hospital of St. Joseph
Belgorod
Sergey Konstantinov
- Recruiting
Kuzbass Cardiology center
Kemerovo
Olga L. Barbarash, MD, Prof
- Recruiting
Center of Neurology and Cardiology
Kirov
Oleg V. Soloviev, MD, prof
- Recruiting
Lipetsk City Hospital No. 4 "Lipetsk-Med"
Lipetsk
Alexandr V. Lubavin, PhD
- Recruiting
E.I. Chazov National Medical Research Center of Cardiology
Moscow, 121552
Sergey N. Tereschenko, MD, Prof, (495) 150-44-19 ext. +7, stereschenko@yandex.ru
Sergey N. Tereschenko, MD, Prof
- Recruiting
F.I. Inozemtsev City Clinical Hospital
Moscow
Eugenia V. Tavlueva, PhD
- Recruiting
Moscow Multidisciplinary Clinical Center "Kommunarka"
Moscow
Anastasia U. Lebedeva, Md, Prof
- Recruiting
S.P. Botkin City Clinical Hospital
Moscow
Yuri V. Karabach, PhD
- Recruiting
S.S. Yudin City Clinical Hospital
Moscow
Natalya V. Yasnopolskaya, MD, PhD
- Recruiting
N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod
Galina V. Kovaleva
- Recruiting
G.A. Zakharyin Clinical hospital №6
Penza
Mikhail V. Timofeev, MD, PhD
- Recruiting
V.P. Polyakov Samara Regional Clinical Cardiology Dispensary
Samara
Dmitry V. Duplyakov, MD, prof
- Recruiting
Tver Regional Clinical Hospital
Tver'
Robert M. Rabinovich, MD, PhD
- Recruiting
City Clinical Hospital of Emergency medicine №25
Volgograd
Eduard A. Ponomarev, MD, prof
About this study
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)
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.
Read the 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.
- Conditions
- Pulmonary Embolism Acute Massive
- Being tested
- Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®
- Keywords
- Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®Drug
Also called Fortelyzin®
Non-immunogenic staphylokinase 15 mg as a single intravenous bolus
| Study group | Role | What they receive |
|---|---|---|
| Non-immunogenic staphylokinase | Drug: non-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin® Receives: Drug: Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
The number of death from any causes during hospitalization
Measured: day 7 after drug administration
Secondary outcomes (4)
All-cause mortality
The number of death from any causes during 30 days after drug administration
Measured: day 30 after drug administration
Haemodynamic Collapse
The number of haemodynamic collapses from any causes during 30 days after drug administration
Measured: day 30 after drug administration
Recurrent Pulmonary Embolism
The number of recurrent pulmonary embolism from any causes during 30 days after drug administration
Measured: day 30 after drug administration
Pulmonary Artery Systolic Pressure Measures
The efficacy is evaluated in terms of pulmonary artery systolic pressure after drug administration
Measured: baseline and day 2 after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jun 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism Acute MassiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Supergene, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Responsible party
- Sponsor
- Investigators
- Sergey N. Tereschenko, MD, Prof., Principal investigator, E.I. Chazov National Medical Research Center of CardiologySergey S. Markin, MD, Prof., Study director, LLC "SuperGene"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245927
- Sponsor's protocol ID
- FORPE Registry
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Haemost. 2025 Feb;23(2):657-667. doi: 10.1016/j.jtha.2024.09.035. Epub 2024 Oct 23.
PubMed 39454884Leontyev 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.
PubMed 40391253
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07245927
- Acronym / sponsor ID
- FORPE Registry
- Conditions
- Pulmonary Embolism Acute Massive
- Keywords
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Supergene, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-immunogenic staphylokinase | – | Drug: 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 Other Names: Fortelyzin® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- Increased risk of bleeding:
- Lactation, pregnancy.
- Known hypersensitivity to the non-immunogenic recombinant staphylokinase.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®Also: Fortelyzin®Non-immunogenic staphylokinase 15 mg as a single intravenous bolus | Drug | Non-immunogenic staphylokinase |
Primary outcome
All-cause mortality
Time frame: day 7 after drug administration
The number of death from any causes during hospitalization
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Results publication: PubMed 39454884Kirienko 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.
- Results publication: PubMed 40391253Leontyev 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergey N. Tereschenko, MD, Prof. principal investigator
E.I. Chazov National Medical Research Center of Cardiology
Sergey S. Markin, MD, Prof. study director
LLC "SuperGene"
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism Acute Massive, run by Supergene, LLC at 14 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergey N. Tereschenko, MD, Prof. (495-150-44-19 ext. +7, stereschenko@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: day 7 after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07245927, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.