Tests a clot-dissolving drug for stroke caused by a blocked blood vessel

Trial details

Who runs it

Supergene, LLC

Trial code

NCT07324837

Record updated

1 October 2026

Original description

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 full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Surgery on the brain or spinal cord in the last 2 months; Previous stroke or severe traumatic brain injury within 3 months; 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); Acute ischemic stroke within 4,5 h after symptom onset; 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; 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; Gastrointestinal or genitourinary bleeding in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer in the last 3 months; History of hemorrhagic stroke or stroke of unspecified genesis; Severe liver disease, including liver failure, liver cirrhosis, portal hypertension (with esophageal varices), active hepatitis; Cancer with an increased risk of bleeding; Hemorrhagic diathesis, including renal and hepatic failure; Data on bleeding or acute trauma (fracture) at the time of examination; 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); Platelet count below 100,000/mm3; 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; Intended to proceed to endovascular treatment; 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; Punctures of non-compressible arteries and veins in the last 7 days; Unable to perform CT or MRI; Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion); Acute pancreatitis; Bacterial endocarditis, pericarditis; Arterial aneurysms, malformations of arteries and veins. Suspected dissecting aortic aneurysm; 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); Pregnant women, nursing mothers, or reluctant to use effective contraceptive measures during the period of trial.

ClinicalTrials.gov NCT07324837