New stroke drug could help patients treated up to 24 hours after symptoms start

NCT ID NCT07324837

First seen Jun 24, 2026 · Last updated Jul 24, 2026 · Updated 4 times

Summary

This Phase 3 trial tests a drug called Fortelyzin® (non-immunogenic staphylokinase) in 990 adults with acute ischemic stroke who can be treated between 4.5 and 24 hours after symptoms begin. Participants receive a single injection of the drug or a placebo. The goal is to see if the drug improves functional outcomes, such as being able to live independently, 90 days later.

What this could mean

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

Active substance
Fortelyzin® (non-immunogenic staphylokinase)
What this could lead to
If successful, this could provide a new treatment option for stroke patients who cannot receive standard therapy within the first few hours, potentially reducing disability.
What could go wrong
This is an early-stage Phase 3 trial, so results may not confirm benefit. There is also a risk of bleeding, as with any clot-busting drug.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • A.K. Yeramishantsev Moscow City Clinical Hospital

    NOT_YET_RECRUITING

    Moscow, 129327, Russia

  • Altai Regional Clinical Hospital

    NOT_YET_RECRUITING

    Barnaul, 656024, Russia

  • Chelyabinsk Regional Clinical Hospital No. 3

    NOT_YET_RECRUITING

    Chelyabinsk, Russia

  • City Clinical Hospital of Emergency Medical Care No. 25

    NOT_YET_RECRUITING

    Volgograd, 400138, Russia

  • F.I. Inozemtsev Moscow City Clinical Hospital

    NOT_YET_RECRUITING

    Moscow, 105187, Russia

  • Interregional Clinical and Diagnostic Center

    NOT_YET_RECRUITING

    Kazan', 420101, Russia

  • Irkutsk Regional Clinical Hospital

    RECRUITING

    Irkutsk, 664079, Russia

  • Kaluga Regional Clinical Hospital

    NOT_YET_RECRUITING

    Kaluga, 248007, Russia

  • Krasnogorsk Clinical Hospital

    NOT_YET_RECRUITING

    Krasnogorsk, 143408, Russia

  • L.A. Vorokhobov Moscow City Clinical Hospital No. 67

    NOT_YET_RECRUITING

    Moscow, 123423, Russia

  • Leningradskaya Regional Clinical Hospital

    RECRUITING

    Saint Petersburg, 194291, Russia

  • Moscow Multidisciplinary Clinical Center "Kommunarka"

    NOT_YET_RECRUITING

    Moscow, 108814, Russia

  • N.A. Semashko Nizhny Novgorod Regional Clinical Hospital

    NOT_YET_RECRUITING

    Nizhny Novgorod, 603126, Russia

  • N.I. Pirogov Russian National Research Medical University

    NOT_YET_RECRUITING

    Moscow, 117997, Russia

  • Ryazan Regional Clinical Hospital

    NOT_YET_RECRUITING

    Ryazan, Ryazan Oblast, 390039, Russia

  • S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1

    RECRUITING

    Krasnodar, 350086, Russia

  • Sergiev Posad District Hospital

    NOT_YET_RECRUITING

    Sergiyev Posad, 141301, Russia

  • St. Petersburg Hospital for War Veterans

    RECRUITING

    Saint Petersburg, 193079, Russia

  • Sverdlovsk Regional Clinical Hospital No. 1

    RECRUITING

    Yekaterinburg, 620102, Russia

  • Tver Regional Clinical Hospital

    RECRUITING

    Tver', 170036, Russia

  • Ulyanovsk Regional Clinical Hospital

    RECRUITING

    Ulyanovsk, Russia

  • V.I. Voynov Orenburg Regional Clinical Hospital

    RECRUITING

    Orenburg, Russia

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