TRACE-5Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5 Improving Neurological Functional Outcomes in Basilar Artery Occlusion With Tenecteplase in Extended Time Window: Multicentre, Prospective, Open-label, Blinded Endpoint (PROBE), Phase 3, Randomized Controlled Trial

Fecha de inicio: 24 de enero de 2024

Inclusion Criteria: 1. Age ≥18. 2. Patients presenting with posterior circulation ischemic stroke symptoms due to near-complete or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration/coma) or the time the patient was last known to be well. 3. Presence of a basilar artery occlusion, proven by CT Angiography or MR Angiography. Basilar artery occlusion will be defined as 'potentially retrievable' occlusion at the basilar artery. This can be a near or complete occlusion. 4. Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week). 5. Local legal requirements for consent have been satisfied. Exclusion Criteria: 1. Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging. 2. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) \<6 on non-contrast CT (NCCT) or CTA-source images or MRI diffusion weighted imaging (DWI). 3. Significant cerebellar mass effect or acute hydrocephalus. 4. Established frank hypodensity on non-contrast CT indicating subacute infarction. 5. Bilateral extensive brainstem ischemia. 6. Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability). 7. Other standard contraindications to intravenous thrombolysis. 8. Contraindication to imaging with contrast agents. 9. Clinically evident pregnant women. 10. Vessel imaging showing both anterior and posterior circulation large vessel occlusion. 11. Current participation in another research drug treatment protocol. 12. Known terminal illness such that the patients would not be expected to survive a year. 13. Planned withdrawal of care or comfort care measures. 14. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.