Tenecteplase in Wake-up Ischaemic Stroke Trial

Inclusion Criteria:

• Stroke symptoms on awakening that were not present before sleep
• Clinical diagnosis of stroke with limb weakness with NIHSS score >=3, or dysphasia
• Treatment with tenecteplase is possible within 4.5 hours of awakening
• Written consent from the patient, non-written consent from the patient (witnessed bynon-participating health care personnel), or written consent from the nearest familymember

Exclusion Criteria:

• Age <18 years
• NIHSS score >25 or NIHSS consciousness score >2, or seizures during stroke onset
• Findings on plain CT that indicate that the patient is unlikely to benefit fromtreatment:
• Infarction comprising more than >1/3 of the middle cerebral artery territory onplain CT or CT perfusion
• Intracranial haemorrhage, structural brain lesions which can mimic stroke (e.gcerebral tumour)
• Active internal bleeding of high risk of bleeding, e.g.:
• Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within theprevious 21 days, or arterial puncture at a non-compressible site within theprevious 7 days
• Any known defect in coagulation, e.g. current use of vitamin K antagonist with anINR >1.7 or prothrombin time >15 seconds, or use of direct thrombin inhibitors ordirect factor Xa inhibitors during the last 24 hours (unless reversal of effectcan be achieved by agents such as idarucizumab) or with elevated sensitivelaboratory tests (such as activated partial thromboplastin time (aPTT),international normalized ratio (INR), platelet count, ecarin clotting time,thrombin time (TT), or appropriate factor Xa activity assays), or heparins duringthe last 24 hours or with an elevated aPTT greater than the upper limit of normal
• Known defect of clotting or platelet function or platelet count below 100,000/mm3 (but patients on antiplatelet agents can be included)
• Ischaemic stroke or myocardial infarction in previous 3 months, previousintracranial haemorrhage, severe traumatic brain injury or intracranial orintraspinal operation in previous 3 months, or known intracranial neoplasm,arteriovenous malformation or aneurysm
• Contraindications to tenecteplase, e.g., acute bacterial endocarditis or pericarditis;acute pancreatitis; severe hepatic dysfunction, including hepatic failure, cirrhosis,portal hypertension; active hepatitis; systemic cancer with increased bleeding risk;haemostatic defect including secondary to severe hepatic, renal disease; organ biopsy;prolonged cardiopulmonary resuscitation > 2 min (within 2 weeks)
• Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg),despite blood pressure lowering treatment
• Blood glucose <2.7 or >20.0 mmol/L (use of finger-stick measurement devices isacceptable)
• Pregnancy, positive pregnancy test, childbirth during last 10 days, or breastfeeding.In any woman of childbearing potential, a pregnancy test must be performed and theresult assessed before trial entry
• Other serious or life-threatening disease before the stroke: severe mental or physicaldisability (e.g. Mini Mental Status score <20, or mRS score ≥3), or life expectancyless than 12 months
• Patient unavailability for follow-up (e.g. no fixed address)