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

NCT07324837

RecruitingPhase 3

Sponsor: Supergene, LLC

Conditions: Ischemic Stroke, Acute

Interventions: non-immunogenic staphylokinase, Placebo

Countries: Russia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (22)
  • Ryazan, Ryazan Oblast, Russia
  • Barnaul, Russia
  • Chelyabinsk, Russia
  • Irkutsk, Russia
  • Kaluga, Russia
  • Kazan', Russia
  • Krasnodar, Russia
  • Krasnogorsk, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Nizhny Novgorod, Russia
  • Orenburg, Russia
  • Saint Petersburg, Russia
  • Saint Petersburg, Russia
  • Sergiyev Posad, Russia
  • Tver', Russia
  • Ulyanovsk, Russia
  • Volgograd, Russia
  • Yekaterinburg, Russia