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New registry to test Clot-Busting injection for severe lung clots

NCT ID NCT07245927

Disease control Sponsor: Supergene, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This registry is studying a drug called non-immunogenic staphylokinase (Fortelyzin®) given as a single injection to dissolve blood clots in the lungs. It will include up to 20,000 adults with massive pulmonary embolism who are already receiving the drug in routine care. The goal is to see how safe and effective it is in real-world settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Non-immunogenic staphylokinase (Fortelyzin®)
What this could lead to
If successful, this could confirm that a single injection of staphylokinase is a safe and effective way to dissolve blood clots in the lungs, potentially improving survival and reducing complications.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. Bleeding risks are a concern, and the drug may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

pulmonary embolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary embolism acute massive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Belgorod Regional Clinical Hospital of St. Joseph

    RECRUITING

    Belgorod, Russia

  • Center of Neurology and Cardiology

    RECRUITING

    Kirov, Russia

  • City Clinical Hospital of Emergency medicine №25

    RECRUITING

    Volgograd, Russia

  • E.I. Chazov National Medical Research Center of Cardiology

    RECRUITING

    Moscow, 121552, Russia

  • F.I. Inozemtsev City Clinical Hospital

    RECRUITING

    Moscow, Russia

  • G.A. Zakharyin Clinical hospital №6

    RECRUITING

    Penza, Russia

  • Kuzbass Cardiology center

    RECRUITING

    Kemerovo, Russia

  • Lipetsk City Hospital No. 4 "Lipetsk-Med"

    RECRUITING

    Lipetsk, Russia

  • Moscow Multidisciplinary Clinical Center "Kommunarka"

    RECRUITING

    Moscow, Russia

  • N.A. Semashko Nizhny Novgorod Regional Clinical Hospital

    RECRUITING

    Nizhny Novgorod, Russia

  • S.P. Botkin City Clinical Hospital

    RECRUITING

    Moscow, Russia

  • S.S. Yudin City Clinical Hospital

    RECRUITING

    Moscow, Russia

  • Tver Regional Clinical Hospital

    RECRUITING

    Tver', Russia

  • V.P. Polyakov Samara Regional Clinical Cardiology Dispensary

    RECRUITING

    Samara, Russia

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