Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset
NCT ID: NCT07324837
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
990 participants
INTERVENTIONAL
2026-02-01
2029-01-01
Brief Summary
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Detailed Description
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In 2020, the non-immunogenic staphylokinase was registered in Russia for the acute ischemic stroke treatment within 4,5 h after the onset of symptoms. In the FRIDA randomized clinical trial the non-immunogenic staphylokinase was non-inferior to alteplase for patients with acute ischaemic stroke. Mortality, symptomatic intracranial haemorrhage, and serious adverse events did not differ significantly between groups. Non-immunogenic staphylokinase is easy to administer with a rapid single bolus of 10 mg regardless patients' bodyweight, simplifying clinical use. In 2024, the non-immunogenic staphylokinase has been included in the updated Russian clinical guidelines for the acute ischemic stroke treatment.
A rapid (10 s) single bolus of the non-immunogenic staphylokinase in patients with acute ischemic stroke may provide significant advantages over a one-hour alteplase administration in the more rapid reperfusion in the first 24 hours after thrombolysis and a greater number of good functional outcomes. It can be assumed that the non-immunogenic staphylokinase usage in patients with acute ischemic stroke outside the 4.5-hour therapeutic window will lead to the restoration of collateral blood flow in the penumbra in comparison with standard medical management.
Therefore, FRIDA-CT trial is aimed to investigate the efficacy and safety of the non-immunogenic staphylokinase within the time window of 4.5-24 hours, wake-up stroke or no witness stroke in patients who had an acute ischaemic stroke with salvageable tissue due to large vessel occlusion.
In the multicenter, double-blind, randomized, placebo-controlled phase III clinical trial patients who had an acute ischaemic stroke due to anterior circulation large vessel occlusion (internal carotid artery, middle cerebral artery M1 and M2 segments) within 4.5-24 hours from last known well (including wake-up stroke and no witness stroke) and with salvageable tissue (ischaemic core volume \<70 mL, mismatch ratio ≥1.8 and mismatch volume ≥15 mL) based on CT perfusion or MRI perfusion-weighted imaging (PWI) will be included and randomised to the non-immunogenic staphylokinase, 10 mg (single bolus) regardless patient's bodyweight or placebo group. Patients who are intended for direct thrombectomy will be excluded from the trial. Follow-up period will be 90 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Non-immunogenic staphylokinase
The non-immunogenic staphylokinase is given as a single intravenous bolus, 10 mg (within 5-10 seconds) immediately upon randomization regardless patient's bodyweight
non-immunogenic staphylokinase
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
Placebo
Placebo
Placebo is given as a single intravenous bolus (within 5-10 seconds) immediately upon randomization
Interventions
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non-immunogenic staphylokinase
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
Placebo is given as a single intravenous bolus (within 5-10 seconds) immediately upon randomization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Supergene, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Nikolay A. Shamalov, MD, prof
Role: PRINCIPAL_INVESTIGATOR
Federal Center for Brain and Neurotechnology of the Federal Medical and Biological Agency of Russia
Sergey S. Markin, MD, prof
Role: STUDY_DIRECTOR
LLC "SuperGene"
Locations
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Ryazan Regional Clinical Hospital
Ryazan, Ryazan Oblast, Russia
Altai Regional Clinical Hospital
Barnaul, , Russia
Chelyabinsk Regional Clinical Hospital No. 3
Chelyabinsk, , Russia
Irkutsk Regional Clinical Hospital
Irkutsk, , Russia
Kaluga Regional Clinical Hospital
Kaluga, , Russia
Interregional Clinical and Diagnostic Center
Kazan', , Russia
S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1
Krasnodar, , Russia
N.I. Pirogov Russian National Research Medical University
Moscow, , Russia
V.I. Voynov Orenburg Regional Clinical Hospital
Orenburg, , 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
Countries
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Central Contacts
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Facility Contacts
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References
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Gusev EI, Martynov MY, Nikonov AA, Shamalov NA, Semenov MP, Gerasimets EA, Yarovaya EB, Semenov AM, Archakov AI, Markin SS; FRIDA Study Group. Non-immunogenic recombinant staphylokinase versus alteplase for patients with acute ischaemic stroke 4.5 h after symptom onset in Russia (FRIDA): a randomised, open label, multicentre, parallel-group, non-inferiority trial. Lancet Neurol. 2021 Sep;20(9):721-728. doi: 10.1016/S1474-4422(21)00210-6.
Shamalov NA, Martynov MY, Yarovaya EB, Chefranova ZY, Kutsenko VA, Semenov AM, Ivanov SV, Semenov MP, Markin SS, Gusev EI; FORPI study group. Thrombolysis With the Nonimmunogenic Staphylokinase for Acute Ischemic Stroke in FORPI Registry: An Observational Study. Stroke. 2025 Nov 26. doi: 10.1161/STROKEAHA.125.051115. Online ahead of print.
Other Identifiers
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FRIDA-CT
Identifier Type: -
Identifier Source: org_study_id
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