Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset
Sponsor: Supergene, LLC • ClinicalTrials.gov ID: NCT07324837
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Multicenter, double-blind, randomized, placebo-controlled phase III clinical trial. At the clinical sites, patients with acute ischemic stroke within 4.5-24 hours of symptom onset will be randomized to receive a single bolus injection of the recombinant non-immunogenic staphylokinase (Fortelyzin®, LLC "SuperGene", Russia) or placebo.
Interventions
-
non-immunogenic staphylokinase
(Drug)
The non-immunogenic staphylokinase is given as a single intravenous bolus, 10 mg (within 5-10 seconds) immediately upon randomization regardless patient's bodyweight
-
Placebo
(Drug)
Placebo is given as a single intravenous bolus (within 5-10 seconds) immediately upon randomization
Eligibility criteria
Conditions
Locations
- Ryazan Regional Clinical Hospital — Ryazan, Ryazan Oblast, Russia
- Chelyabinsk Regional Clinical Hospital No. 3 — Chelyabinsk, Russia
- Irkutsk Regional Clinical Hospital — Irkutsk, Russia
- Interregional Clinical and Diagnostic Center — Kazan', Russia
- S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1 — Krasnodar, Russia
- Krasnogorsk Clinical Hospital — Krasnogorsk, Russia
- Moscow Multidisciplinary Clinical Center "Kommunarka" — Moscow, Russia
- N.I. Pirogov Russian National Research Medical University — Moscow, Russia
- N.A. Semashko Nizhny Novgorod Regional Clinical Hospital — Nizhny Novgorod, Russia
- V.I. Voynov Orenburg Regional Clinical Hospital — Orenburg, Russia
- St. Petersburg Hospital for War Veterans — Saint Petersburg, Russia
- Leningradskaya Regional Clinical Hospital — Saint Petersburg, Russia
- Sergiev Posad District Hospital — Sergiyev Posad, Russia
- Tver Regional Clinical Hospital — Tver', Russia
- Ulyanovsk Regional Clinical Hospital — Ulyanovsk, Russia
- City Clinical Hospital of Emergency Medical Care No. 25 — Volgograd, Russia
- Sverdlovsk Regional Clinical Hospital No. 1 — Yekaterinburg, Russia
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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