A multicentre study evaluating the safety of reperfusion thrombolytic therapy with intravenous recombinant tissue plasminogen activator (rtPA) for ischaemic stroke in patients on the non-vitamin K antagonist oral anticoagulant after reversing anticoagulant activity with a specific antidote.

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• INTERVENTIONAL PART OF THE STROACT STUDY: 1. Occlusion of a large intracranial vessel in CT/MR angiography (CTA/MRA), corresponding to the current acute neurological deficit being an indication for primary mechanical thrombectomy. 2. Significant disability prior to the current stroke event defined as >2 points on the modified Rankin Scale (mRS) and/or significant impairment of the cognitive function prior to AIS (the latter documented in patient’s medical records). 3. Mild and rapidly improving neurological deficit with high probability of complete recovery. 4. Clinically severe stroke with >18 points in NIHSS. 5. Neuroimaging findings that might be responsible for acute neurological deficit (“stroke mimics”) and/or are contraindications for standard thrombolytic treatment: such as intracranial and/or intracerebral bleeding, tumours, abscesses and other. 6. Treatment with the following anticoagulants: a. Oral vitamin K antagonist (warfarin, acenocumarol), b. Unfractionated heparin, c. Low molecular weight heparin, or d. Inhibitors of coagulation factor IIa (dabigatran) and Xa other than rivaroxaban or apixaban 7. Whole blood, and/or blood clotting factors (such as: prothrombin complex concentrate [PCC], recombinant factor VIIa [rVIIa], fresh frozen plasma [FFP]) administered within 7 days before study treatment initiation. 8. Anti-Xa activity (which is assumed to be directly proportional to the DOAC plasma concentration) is <50 ng/mL. 9. CT or MRI initial lesion volume >1/2 of the anatomical perfusion area of the middle cerebral artery (MCA), or anterior cerebral artery (ACA), or posterior cerebral artery (PCA). 10. Suspected subarachnoid haemorrhage based on specific symptomatology and/or physical examination (even if CT/MRI is normal). 11. Any history of subarachnoid or intracerebral haemorrhage, so not including previous (currently normal in neuroimaging) traumatic sub-or epidural hematomas > 6 months before the current acute stroke. 12. Any past (chronic) medical illnesses that significantly impair patient’s functional status down to mRS 3 points or more (thus not only related to CNS pathologies and including cognitive impairment), and/or with a poor prognosis (e.g., neoplasms individually assessed to be of poor prognosis). NOTE: Patients after treatment of intracranial aneurysm may be considered for recruitment into the STROACT trial if the procedure was performed > 3 months prior to enrollment. 13. History of major surgery / trauma within 2 months before the current acute stroke. 14. History of acute ischemic stroke or any other medical condition treated with intravenous thrombolysis, or ischemic stroke treated with mechanical thrombectomy, within the 72 hours preceding the current patient’s stroke symptoms. 15. Recent (within 10 preceding days) traumatic external heart massage, obstetrical delivery, lumbar puncture, any puncture of a non-compressible blood vessel. 16. Recent (within 4 preceding weeks) myocardial infarction. 17. Severe trauma at the onset of acute ischemic stroke (e.g., skull fracture, long bone fracture, pelvic fracture). 18. Expected need for major surgery within 72 hours after enrollment (e.g., laparotomy, hip femoral/pelvic fracture surgery, endarterectomy). 19.Cerebral venous sinus thrombosis (CVST). 20.Pulmonary embolism. 21.Suspected infective endocarditis and/or pericarditis. 22.Acute pancreatitis. 23.Systemic or suspected cerebral vasculitis.
• OBSERVATIONAL PART OF THE STROACT STUDY: 1.Occlusion of a large intracranial vessel in CT/MR angiography (CTA/MRA), corresponding to the current acute neurological deficit being an indication for primary mechanical thrombectomy. NOTE 1: Patients who qualified to the mechanical thrombectomy cannot be enrolled to the observational part of the STROACT study. 2. Significant disability prior to the current stroke event defined as >2 points on the modified Rankin Scale (mRS) and/or significant impairment of the cognitive function prior to AIS (the latter documented in patient’s medical records). 3. Neuroimaging findings that might be responsible for acute neurological deficit (“stroke mimics”). 4. Treatment with the following anticoagulants: a. Oral vitamin K antagonist (warfarin, acenocumarol), b. Unfractionated heparin, c. Low molecular weight heparin, or d. Inhibitors of coagulation factor IIa/Xa other than dabigatran, rivaroxaban or apixaban 5. Whole blood, and/or blood clotting factors (such as: prothrombin complex concentrate [PCC], recombinant factor VIIa [rVIIa], fresh frozen plasma [FFP]) administered within 7 days before enrollment to the study. 6. Anti-IIa/Xa activity (which is assumed to be directly proportional to the DOAC plasma concentration) is <50 ng/. 7. Suspected subarachnoid haemorrhage based on specific symptomatology and/or physical examination (even if CT/MRI is normal). 8. Any past (chronic) medical illnesses that significantly impairs patient’s functional status down to mRS 3 points or more (thus not only related to CNS pathologies and including cognitive impairment), and/or with a poor prognosis (e.g., neoplasms individually assessed to be of poor prognosis). 9. Cerebral venous sinus thrombosis (CVST). 10. Pulmonary embolism. 11. Systemic or suspected cerebral vasculitis. 12. Congenital or acquired coagulopathy presenting with: a. Prolonged aPTT above 30% of the upper limit of normal (local laboratory reference range), b. Increased INR ≥1.7 13. Severe liver disease including acute hepatic failure, cirrhosis with/or without portal hypertension. 14. Pregnancy. 15. Predicted life expectancy <3 months. 16. Participation in another clinical trial at the time of enrollment or planned inclusion in another clinical trial within less than 90 days of enrollment, provided that protocols of these trials interfere pathophysiologicaly or formally and administratively with the STROACT study. 17. Previous participation in the current clinical trial. 18. Advanced renal failure (eGFR <30 mL/min/1.73m2). 19. Active infection with SARS-CoV-2 (up to 10 days from the first positive testing with any recommended assay or from the first symptoms of infection or severe “long” COVID-19 / severe Post-COVID Neurological Syndrome).