Tenecteplase for the treatment of acute stroke in the late time window before inter-hospital transfer for thrombectomy: a randomized controlled trial

Prior treatment

• Participation in other interventional research (RIPH 1, clinical drug trials, clinical investigations) for the duration of their follow-up

Other illness

• Pre-stroke mRS > 2 (significant disability, unable to carry out all usual duties and activities independently before stroke)

Lab values

• Any contraindication to IVT, based on the Metalyse SmPC and the latest AHA/ASA guidelines on IVT (Prabhakaran et al. Stroke. 2026), other than the time criteria: • Persistent incapacity to lower blood pressure under 185/110 mmHg • Respiratory or hemodynamic failure • Hypersensitivity to the active substance or to any of its excipients or hypersensitivity to gentamicin (a trace residue from the manufacturing process • Known haemorrhagic diathesis • Bacterial endocarditis, pericarditis • Acute pancreatitis • Significant impairment of hepatic function, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and progressive hepatitis • Active ulcerative gastrointestinal disease • Neoplasia associated with an increased risk of haemorrhage • Known bleeding disorders, such as thrombocytopenia (platelet count < 100 G/L) or severe coagulopathy (INR > 1.7, activated partial thromboplastin time > 40s or prothrombin time > 15s) either currently or within the last 3 weeks • Treatment with effective doses of oral anticoagulants (e.g. vitamin K antagonists with an INR > 1.7) • Any history of intracerebral neoplasm • History of intracranial / spinal surgery or acute spinal cord injury within 3 months • Recent ST-segment elevation myocardial infarction within 3 months • Major non-central nervous system surgery, biopsy of a parenchymal organ or significant trauma within the last 10 days • Recent moderate to severe traumatic brain injury • Known arterial or venous malformation, except unruptured intracranial aneurysm • History of intracerebral haemorrhage within 3 months • Known cerebral amyloid angiopathy • History of acute ischaemic stroke within 3 months

Other

• Known pregnant or breast-feeding woman
• Patient benefiting from legal protection

• Age ≥18 years old
• Admitted in a PSC within 4.5-to-24-hours from stroke symptom onset (or last know well time if symptom onset was not observed)
• Baseline NIHSS score ≥6
• Imaging evidence of a large vessel occlusion (intracranial internal carotid artery [ICA], first or second segment of the middle cerebral artery M1 or proximal M2 or basilar artery)
• Target mismatch profile as evidenced by one of the below criteria • If perfusion imaging is available: CT- or MR-perfusion mismatch: occlusion of ICA or M1 or M2 and an estimated ischemic core volume ≤70 mL, a Tmax 6 volume ≥30 mL, a mismatch ratio ≥1.8, and a mismatch volume ≥15 mL • If perfusion imaging is not available: MRA/CTA-ASPECTS mismatch: occlusion of ICA or M1 and ASPECTS score ≥6, or M2 and ASPECTS score ≥7, or basilar and pc-ASPECTS ≥7 (ASPECTS can be assessed on DWI or non-contrast CT)
• Patients requiring inter-hospital transfer for an endovascular procedure.