Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Ischemic Stroke, Acute

In brief

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.

Key facts

Study ID

NCT07324837

Run by

Supergene, LLC

People needed

990

Starts

2026-06-09

Expected to finish

2029-01-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 18 years and over;
• Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrolment, including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
• Pre-stroke modified Rankin scale (mRS) score≤1;
• Internal carotid artery, middle cerebral artery M1 or M2 occlusion confirmed by CT/MRI, internal carotid artery, middle cerebral artery M1 or M2 being responsible for signs and symptoms of acute ischemic stroke;
• Neuroimaging: target mismatch profile on CT or MRI perfusion: ischemic core volume <70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL;
• Alberta Stroke Program Early CT score (ASPECTS) > 6;
• Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive);
• The patient is not planned or cannot undergo thrombectomy or intravenous thrombolysis in accordance with the current version of the Clinical Guidelines;
• Written informed consent from patients or their legally authorized representatives.

You may not qualify if…

• Acute ischemic stroke within 4,5 h after symptom onset;
• Intended to proceed to endovascular treatment;
• Known hypersensitivity to the non-immunogenic staphylokinase;
• Convulsive seizures at the onset of the disease, if there is no certainty that the seizure is a clinical manifestation of acute ischemic stroke;
• Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), and the inability to reduce systolic blood pressure below 180 mmHg or diastolic blood pressure below 105 mmHg;
• Blood glucose <2.8 or >22.2 mmol/L (after blood glucose level correction to the specified values, inclusion of the patient in the study is possible);
• Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumor, arteriovenous malformation, brain abscess, cerebral aneurysm;
• Subarachnoid hemorrhage;
• Major bleeding currently or within the past 6 months;
• Surgery on the brain or spinal cord in the last 2 months;
• Punctures of non-compressible arteries and veins in the last 7 days;
• Gastrointestinal or genitourinary bleeding in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer in the last 3 months;
• Platelet count below 100,000/mm3;
• Previous stroke or severe traumatic brain injury within 3 months;
• Unable to perform CT or MRI;
• History of hemorrhagic stroke or stroke of unspecified genesis;
• Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion);
• Concomitant use of indirect oral anticoagulants (warfarin) with INR > 1.7;
• Taking direct anticoagulants (heparin, heparinoids) in the previous 48 hours with an APTT value above normal;
• Taking new oral anticoagulants in the previous 48 hours with a thrombin time value above normal and the impossibility of administering the specific antagonist idarucizumab (for dabigatran) or the presence of anti-Xa activity (for rivaroxaban, apixaban and edoxaban).
• Severe liver disease, including liver failure, liver cirrhosis, portal hypertension (with esophageal varices), active hepatitis;
• Acute pancreatitis;
• Bacterial endocarditis, pericarditis;
• Arterial aneurysms, malformations of arteries and veins. Suspected dissecting aortic aneurysm;
• Cancer with an increased risk of bleeding;

Where it is running

• V.I. Voynov Orenburg Regional Clinical Hospital — Orenburg, Russia (enrolling)
• St. Petersburg Hospital for War Veterans — Saint Petersburg, Russia (enrolling)
• Leningradskaya Regional Clinical Hospital — Saint Petersburg, Russia (enrolling)
• S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1 — Krasnodar, Russia (enrolling)
• Tver Regional Clinical Hospital — Tver', Russia (enrolling)
• Ulyanovsk Regional Clinical Hospital — Ulyanovsk, Russia (enrolling)
• Irkutsk Regional Clinical Hospital — Irkutsk, Russia (enrolling)
• Sverdlovsk Regional Clinical Hospital No. 1 — Yekaterinburg, Russia (enrolling)
• N.I. Pirogov Russian National Research Medical University — Moscow, Russia
• Ryazan Regional Clinical Hospital — Ryazan, Ryazan Oblast, Russia
• A.K. Yeramishantsev Moscow City Clinical Hospital — Moscow, Russia
• N.A. Semashko Nizhny Novgorod Regional Clinical Hospital — Nizhny Novgorod, Russia
• Sergiev Posad District Hospital — Sergiyev Posad, Russia
• City Clinical Hospital of Emergency Medical Care No. 25 — Volgograd, Russia
• L.A. Vorokhobov Moscow City Clinical Hospital No. 67 — Moscow, Russia
• Altai Regional Clinical Hospital — Barnaul, Russia
• Chelyabinsk Regional Clinical Hospital No. 3 — Chelyabinsk, Russia
• Kaluga Regional Clinical Hospital — Kaluga, Russia
• Interregional Clinical and Diagnostic Center — Kazan', Russia
• Krasnogorsk Clinical Hospital — Krasnogorsk, Russia
• F.I. Inozemtsev Moscow City Clinical Hospital — Moscow, Russia
• Moscow Multidisciplinary Clinical Center "Kommunarka" — Moscow, Russia

Full record on ClinicalTrials.gov

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