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New clot-busting shot could save lives in dangerous lung condition

NCT ID NCT06362746

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a single injection of a clot-dissolving drug (staphylokinase) in 486 adults with intermediate high-risk pulmonary embolism—a serious blood clot in the lungs. The goal is to see if it prevents death, heart collapse, or another clot compared to a placebo. Participants must have a confirmed clot and signs of heart strain but stable blood pressure.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 486 people

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

Started

May 2024

Expected to finish

Dec 2028

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.

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 and over. * Verified diagnosis of intermediate high-risk PE using CTPA, no more than two weeks from the symptoms onset. * RV dysfunction, defined as a RV/LV ventricular end-diastolic diameter ratio more than 1.0 assessed by CTPA. * Increased risk of early death or hemodynamic collapse, defined by one of the following criteria: 1. systolic blood pressure less than 110 mm Hg, but not less than 90 mm Hg for more than 15 minutes; 2. respiratory rate more than 20 per minute or SpO2 less than 90% without oxygen support; 3. chronic heart failure with left ventricular ejection fraction less than 40%. * Serum troponin I level more than 14 pg/mL in patients under 75 years, and more than 45 pg/mL in patients aged 75 years or older. * Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after: * women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year); * men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility). * Availability of signed and dated informed consent of the patient to participate in the study. Exclusion Criteria: * High-risk PE with hemodynamic instability. * 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

How to take part

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

  1. The places running it

    21 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

  • Asinovskaya District Hospital

    COMPLETED

    Asino, Tomsk Oblast, 636840, Russia

  • Belgorod Regional Clinical Hospital of St. Joseph

    RECRUITING

    Belgorod, 308007, Russia

  • Center of Neurology and Cardiology

    RECRUITING

    Kirov, 610035, Russia

  • City Clinical Hospital of Emergency medicine №25

    RECRUITING

    Volgograd, 400138, Russia

  • City Clinical Hospital №4

    WITHDRAWN

    Perm, 614107, Russia

  • City Hospital No. 15

    RECRUITING

    Saint Petersburg, 198205, Russia

  • City Hospital No. 26

    RECRUITING

    Saint Petersburg, 196247, Russia

  • F.I. Inozemtsev City Clinical Hospital

    RECRUITING

    Moscow, 105187, Russia

  • G.A. Zakharyin Clinical hospital №6

    RECRUITING

    Penza, 440071, Russia

  • Kuzbass Cardiology center

    RECRUITING

    Kemerovo, 650002, Russia

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

    RECRUITING

    Lipetsk, 398006, Russia

  • Moscow Multidisciplinary Clinical Center "Kommunarka"

    RECRUITING

    Moscow, 108814, Russia

  • N.A. Semashko Nizhny Novgorod Regional Clinical Hospital

    RECRUITING

    Nizhny Novgorod, 603093, Russia

  • N.N. Burdenko Penza Regional Clinical hospital

    WITHDRAWN

    Penza, 440026, Russia

  • RZD Medicine hospital

    RECRUITING

    Barnaul, Altayskiy Kray, 656038, Russia

  • Regional Clinical Hospital №2

    RECRUITING

    Krasnodar, 350012, Russia

  • S.P. Botkin City Clinical Hospital

    RECRUITING

    Moscow, Russia

  • S.S. Yudin City Clinical Hospital

    RECRUITING

    Moscow, 115446, Russia

  • Tomsk regional cilinical hospital

    RECRUITING

    Tomsk, 634063, Russia

  • Tver Regional Clinical Hospital

    RECRUITING

    Tver', 170036, Russia

  • Ufa Emergency City Hospital

    RECRUITING

    Ufa, 450092, Russia

  • V.F. Dolgopolov Vyselki Central District Hospital

    RECRUITING

    Vyselki, Krasnodarskiy Kray, 353100, Russia

  • V.M. Buyanov City Clinical Hospital

    RECRUITING

    Moscow, 115516, Russia

  • V.P. Polyakov Samara Regional Clinical Cardiology Dispensary

    RECRUITING

    Samara, 443070, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.