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

Condition studied

Acute ischemic stroke

Investigational medicinal product(s)

Every trial of Tenecteplase across our registers →

Eligibility

Primary endpoint

Functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score, merging categories 5-6 in ordinal analysis. The mRS will be centrally collected by trained professionals blinded to the treatment allocation, based on a phone interview with the patient and/or caregiver.

Endpoint detail

mRS 0 to 1 at 90 days, mRS 0 to 2 at 90 days, Any EVT procedure performed, defined as at least one EVT pass, eTICI score of 2b, 2c or 3 on the first angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer), eTICI score of 2b, 2c or 3 on the final angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer)., Change in NIHSS score between baseline (time of randomization) and arrival at EVT-capable stroke center (before EVT)., Improvement in NIHSS score between baseline (time of randomization) and 24-36 hours of ≥8 points or an NIHSS score ≤1 at 24-36 hours., EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-3L)., Parenchymal hemorrhage type 1 or 2 assessed according to the Heidelberg classification on a follow-up brain imaging within 36 hours of randomization., Any intracranial hemorrhagic transformation according to the Heidelberg classification on a brain imaging within 36 hours of randomization that is causally associated with an NIHSS increase ≥ 4 points, All-cause death at 90 days