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.
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;
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;
Parallel
non-immunogenic staphylokinase
DrugThe non-immunogenic staphylokinase is given as a single intravenous bolus, 10 mg (within 5-10 seconds) immediately upon randomization regardless patient's bodyweight
Placebo
DrugPlacebo is given as a single intravenous bolus (within 5-10 seconds) immediately upon randomization
Excellent functional outcome
The number of patients with excellent functional outcome defined as an mRS score 0-1 at 90 days
Ordinal distribution of mRS
Ordinal distribution of mRS at 90 days
Functional independence outcome
The number of patients with functional independence defined by an mRS score 0-2 point at 90 days
NIHSS change from baseline
NIHSS median change from baseline on discharge
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.
Hemorrhagic transformation
Rate of hemorrhagic transformation according to The Heidelberg Bleeding Classification within 24 hours
Symptomatic intracranial hemorrhage
Rate of symptomatic intracranial hemorrhage (sICH) (as defined by The European Cooperative Acute Stroke Study III criteria \[ECASSIII\] and Safe Implementation of Thrombolysis in Stroke-Monitoring Study \[SITS-MOST\]) within 24 hours
Major bleeding
Rate of major bleeding at 90 days (as defined by the Bleeding Academic Research Consortium (BARC) scale: type 3 and type 5)
Serious adverse events (SAEs)
Rate of serious adverse events (SAEs) within 90 days
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