Single Bolus Non-immunogenic Staphylokinase in Acute Ischemic Stroke (4.5–24 hours)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, double-blind, randomized, placebo-controlled Phase 3 trial evaluating a single bolus of Fortelyzin non-immunogenic staphylokinase in adults with acute ischemic stroke 4.5 to 24 hours after onset. Eligible participants have imaging-confirmed vessel occlusion and favorable perfusion mismatch, with limited or no access to thrombectomy or IV thrombolysis per guidelines. The primary goal is to determine whether the staphylokinase bolus improves functional outcome at follow-up compared with placebo, while monitoring safety endpoints such as intracranial hemorrhage and mortality. The intervention is designed for rapid administration independent of weight. The study builds on prior data suggesting non-immunogenic staphylokinase can be safely administered as a single bolus and may provide faster reperfusion in this extended time window.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men and women aged 18 years and over;
2. 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";
3. Pre-stroke modified Rankin scale (mRS) score≤1;
4. 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;
5. Neuroimaging: target mismatch profile on CT or MRI perfusion: ischemic core volume \<70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL;
6. Alberta Stroke Program Early CT score (ASPECTS) \> 6;
7. Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive);
8. The patient is not planned or cannot undergo thrombectomy or intravenous thrombolysis in accordance with the current version of the Clinical Guidelines;
9. Written informed consent from patients or their legally authorized representatives.

Exclusion Criteria:

1. Acute ischemic stroke within 4,5 h after symptom onset;
2. Intended to proceed to endovascular treatment;
3. Known hypersensitivity to the non-immunogenic staphylokinase;
4. Convulsive seizures at the onset of the disease, if there is no certainty that the seizure is a clinical manifestation of acute ischemic stroke;
5. 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;
6. 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);
7. Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumor, arteriovenous malformation, brain abscess, cerebral aneurysm;
8. Subarachnoid hemorrhage;
9. Major bleeding currently or within the past 6 months;
10. Surgery on the brain or spinal cord in the last 2 months;
11. Punctures of non-compressible arteries and veins in the last 7 days;
12. Gastrointestinal or genitourinary bleeding in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer in the last 3 months;
13. Platelet count below 100,000/mm3;
14. Previous stroke or severe traumatic brain injury within 3 months;
15. Unable to perform CT or MRI;
16. History of hemorrhagic stroke or stroke of unspecified genesis;
17. Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion);
18. Concomitant use of indirect oral anticoagulants (warfarin) with INR \> 1.7;
19. Taking direct anticoagulants (heparin, heparinoids) in the previous 48 hours with an APTT value above normal;
20. 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).
21. Severe liver disease, including liver failure, liver cirrhosis, portal hypertension (with esophageal varices), active hepatitis;
22. Acute pancreatitis;
23. Bacterial endocarditis, pericarditis;
24. Arterial aneurysms, malformations of arteries and veins. Suspected dissecting aortic aneurysm;
25. Cancer with an increased risk of bleeding;
26. Major surgeries or severe injuries within the last 14 days, minor surgeries or invasive procedures within the last 10 days;
27. Prolonged or traumatic cardiopulmonary resuscitation (more than 2 minutes);
28. Hemorrhagic diathesis, including renal and hepatic failure;
29. Data on bleeding or acute trauma (fracture) at the time of examination;
30. Pregnant women, nursing mothers, or reluctant to use effective contraceptive measures during the period of trial.

Where it's running

• Chelyabinsk Regional Clinical Hospital No. 3
  Chelyabinsk, Russia Recruiting
• Irkutsk Regional Clinical Hospital
  Irkutsk, Russia Recruiting
• S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1
  Krasnodar, Russia Recruiting
• V.I. Voynov Orenburg Regional Clinical Hospital
  Orenburg, Russia Recruiting
• St. Petersburg Hospital for War Veterans
  Saint Petersburg, Russia Recruiting
• Leningradskaya Regional Clinical Hospital
  Saint Petersburg, Russia Recruiting

Study contacts

• Principal investigator: Nikolay A. Shamalov, MD, prof — Federal Center for Brain and Neurotechnology of the Federal Medical and Biological Agency of Russia
• Study coordinator: Nikolay A. Shamalov, MD, prof
• Email: shamalovn@gmail.com
• Phone: (499) 936-99-37

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.