A Multicentre, Prospective, Randomized, Open Label, Blinded-endpoint Trial to Optimize Intravenous Tenecteplase Use in Acute Ischemic Stroke Patients Within a Global Adaptive Platform Trial

What this Trial Is About

Researchers are evaluating the use of intravenous thrombolysis (IVT) with tenecteplase for patients who have suffered an acute ischemic stroke (AIS). This study aims to compare the effectiveness of standard-dose tenecteplase (0.25 mg/kg body weight) against a lower dose (0.18 mg/kg) and also to assess scenarios where no tenecteplase is given upfront, particularly in patients recently taking direct oral anticoagulants (DOACs) or those planned for emergency endovascular thrombectomy (EVT). The trial seeks to provide clearer guidance on dosing and treatment choices, especially for specific patient groups like the elderly or those with other health conditions. Participants are randomly assigned to one of three groups: receiving standard-dose tenecteplase, low-dose tenecteplase, or no tenecteplase upfront if eligible for EVT or recently taking DOACs. Tenecteplase is administered as a single intravenous bolus shortly after randomization. The study design is open-label with blinded endpoint assessment and follows patients for 90 days after treatment or until death. During the study, patients will have their functional outcomes measured using the modified Rankin Scale at 90 days, with assessments done by telephone. Researchers will also track mortality, quality of life, serious adverse events, intracranial hemorrhages, and imaging outcomes related to brain infarcts and reperfusion success after EVT. Hospital stay length and ambulatory status at discharge will be recorded. Safety monitoring occurs up to 36 hours post-treatment, with imaging reviewed by blinded experts. The total participant involvement lasts up to 90 days from enrollment.

ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632