Ischemic Stroke, AcutePhase 3FRIDA-CTNCT07324837
Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset
A Phase 3 study testing non-immunogenic staphylokinase in people with Ischemic Stroke, Acute, run by Supergene, LLC at 17 sites in Russia.
Trial summary
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"… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- non-immunogenic staphylokinase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 990 participants
- Where
- 17 sitesRussia
- Study dates
- 9 Jun 2026to 1 Jan 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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;
- Major surgeries or severe injuries within the last 14 days, minor surgeries or invasive procedures within the last 10 days;
- Prolonged or traumatic cardiopulmonary resuscitation (more than 2 minutes);
- Hemorrhagic diathesis, including renal and hepatic failure;
- Data on bleeding or acute trauma (fracture) at the time of examination;
- Pregnant women, nursing mothers, or reluctant to use effective contraceptive measures during the period of trial.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Russia17 sites, 17 recruiting
- Recruiting
Chelyabinsk Regional Clinical Hospital No. 3
Chelyabinsk
Dmitry V. Popov, PhD, Dmitry_popov2001@mail.ru
Dmitry V. Popov, PhD
- Recruiting
Irkutsk Regional Clinical Hospital
Irkutsk, 664079
Ivan V. Korobeynikov, PhD, Irk.ivan@gmail.com
Ivan V. Korobeynikov, PhD
- Not yet recruiting
Interregional Clinical and Diagnostic Center
Kazan', 420101
Dina R. Khasanova, MD, Prof, dhasanova@mail.ru
Dina R. Khasanova, MD, Prof
- Recruiting
S.V. Ochapovsky Research Institute - Regional Clinical Hospital No. 1
Krasnodar, 350086
Ludmila V. Timchenko, MD, prof, tlv2908@yandex.ru
Ludmila V. Timchenko, MD, prof
- Not yet recruiting
Krasnogorsk Clinical Hospital
Krasnogorsk, 143408
Svetlana V. Alexandrova, (498) 602-03-73 ext. +7, clairalex@mail.ru
Svetlana V. Alexandrova
- Not yet recruiting
Moscow Multidisciplinary Clinical Center "Kommunarka"
Moscow, 108814
Denis N. Protsenko, PhD, (495) 744-07-03 ext. +7, ProtsenkoDN@zdrav.mos.ru
Denis N. Protsenko, PhD
- Not yet recruiting
N.I. Pirogov Russian National Research Medical University
Moscow, 117997
Larisa L. Korsunskaya, MD, Prof, neurocrimea@mail.ru
Larisa L. Korsunskaya, MD, Prof
- Not yet recruiting
N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod, 603126
Valentina N. Nesterova, PhD, (831) 438-95-38 ext. +7, nesterova-78@mail.ru
Valentina N. Nesterova, PhD
- Recruiting
V.I. Voynov Orenburg Regional Clinical Hospital
Orenburg
Alexandr N. Chirkov, PhD, log82@mail.ru
Alexandr N. Chirkov, PhD
- Not yet recruiting
Ryazan Regional Clinical Hospital
Ryazan, Ryazan Oblast, 390039
Sergei B. Aksentyev, PhD, aksentievs@mail.ru
Sergei B. Aksentyev, PhD
- Recruiting
St. Petersburg Hospital for War Veterans
Saint Petersburg, 193079
Maria A. Privalova, PhD, (812) 670-94-44 ext. +7, privamariya@yandex.ru
Maria A. Privalova, PhD
- Recruiting
Leningradskaya Regional Clinical Hospital
Saint Petersburg, 194291
Natalya V. Zhukovskaya, MD, prof, nataly.lokb@mail.ru
Natalya V. Zhukovskaya, MD, prof
- Not yet recruiting
Sergiev Posad District Hospital
Sergiyev Posad, 141301
Anton G. Koledinsky, MD, PhD, (496) 542-22-84 ext. +7, koledant@mail.ru
Anton G. Koledinsky, MD, PhD
- Recruiting
Tver Regional Clinical Hospital
Tver', 170036
Ksenia V. Khoroshavina, (482) 277-54-65 ext. +7, kseniarep@mail.ru
Ksenia V. Khoroshavina
- Recruiting
Ulyanovsk Regional Clinical Hospital
Ulyanovsk
Irina V. Greshnova, PhD, tonuus@mail.ru
Irina V. Greshnova, PhD
- Recruiting
City Clinical Hospital of Emergency Medical Care No. 25
Volgograd, 400138
Eduard A. Ponomarev, MD, prof, ponomarev67@mail.ru
Eduard A. Ponomarev, MD, prof
- Recruiting
Sverdlovsk Regional Clinical Hospital No. 1
Yekaterinburg, 620102
Andrey M. Alasheev, MD, prof, alasheev@live.ru
Andrey M. Alasheev, MD, prof
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Efficacy and Safety of the Recombinant Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset (FRIDA-CT)
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.
Read the detailed description
The current guidelines recommended intravenous thrombolysis as the first-line treatment for acute large vessel occlusion of anterior circulation stroke within 4.5 hours of stroke onset. However, a majority of patients arrive in the hospital outside the 4.5-hour time window, who could not receive intravenous thrombolysis.
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
- Ischemic Stroke, Acute
- Being tested
- non-immunogenic staphylokinase, Placebo
- Keywords
- Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-immunogenic staphylokinaseDrug
Also called Fortelyzin®
The non-immunogenic staphylokinase is given as a single intravenous bolus, 10 mg (within 5-10 seconds) immediately upon randomization regardless patient's bodyweight
PlaceboDrug
Placebo is given as a single intravenous bolus (within 5-10 seconds) immediately upon randomization
| Study group | Role | What they receive |
|---|---|---|
| Non-immunogenic staphylokinase | Experimental | The non-immunogenic staphylokinase is given as a single intravenous bolus, 10 mg (within 5-10 seconds) immediately upon randomization regardless patient's bodyweight Receives: Drug: non-immunogenic staphylokinase |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent functional outcome
The number of patients with excellent functional outcome defined as an mRS score 0-1 at 90 days
Measured: 90 days
Secondary outcomes (6)
Ordinal distribution of mRS
Ordinal distribution of mRS at 90 days
Measured: 90 days
Functional independence outcome
The number of patients with functional independence defined by an mRS score 0-2 point at 90 days
Measured: 90 days
NIHSS change from baseline
NIHSS median change from baseline on discharge
Measured: 7-14 days
The rate of improvement on reperfusion
The number of patients with recanalization of 2 and 3 points on the arterial occlusion scale (rAOL) 24 hours after drug administration according to CT (MRI) angiography, where 0 points - complete occlusion, 3 points - complete recanalization.
Measured: 24 hours
All-cause mortality
Rate of all-cause mortality within 90 days
Measured: 90 days
Poor functional outcome
The number of patients with poor functional outcome defined by an mRS score 5-6 point at 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start9 Jun 2026
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Supergene, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikolay A. Shamalov, MD, prof, Principal investigator, Federal Center for Brain and Neurotechnology of the Federal Medical and Biological Agency of RussiaSergey S. Markin, MD, prof, Study director, LLC "SuperGene"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324837
- Sponsor's protocol ID
- FRIDA-CT
- Acronym
- FRIDA-CT
- Status last verified
- Sep 2026
- First submitted
- 23 Dec 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The funder of the study is committed to the responsible sharing of data from FRIDA-CT trail. Data will be provided to any qualified investigator on reasonable request. Deidentified participant data will be available after the publication of the results of the completed study on request to the corresponding author.
Publications
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.
PubMed 34418399Shamalov 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 Non-Immunogenic Staphylokinase for Acute Ischemic Stroke in the FORPI Registry: An Observational Study. Stroke. 2026 Feb;57(2):394-403. doi: 10.1161/STROKEAHA.125.051115. Epub 2025 Nov 26.
PubMed 41293810