Trial of Tenecteplase Versus Standard Care for Basilar Artery Occlusion Stroke Within 24 Hours to Improve Recovery

What this Trial Is About

This research aims to evaluate treatments for patients who arrive at the emergency department with acute ischemic stroke caused by basilar artery occlusion within 24 hours of symptom onset. The study compares the use of tenecteplase, a clot-busting drug, against standard care which may include alteplase or no thrombolytic treatment, with the goal of improving functional outcomes at 90 days after stroke. It is a multi-arm, multi-stage, randomized trial designed to adaptively assess treatment effects and proceed seamlessly from phase 2b to phase 3 based on early results. Participants are randomly assigned to one of two groups one receiving intravenous tenecteplase at a dose of 0.25 mgkg given as a quick bolus, and the other receiving standard care that may include intravenous alteplase at 0.9 mgkg or no thrombolytic treatment. Both groups may undergo mechanical thrombectomy if deemed necessary by their treating doctors. The study uses a computer-based randomization process and will monitor patients through an adaptive sample size plan, with a minimum of 320 and up to 688 patients over about five years. During the trial, participants will be followed for 12 months. Researchers will assess stroke recovery using the modified Rankin Scale at 90 days as the primary outcome, along with other measures like quality of life, early clinical improvement, and safety outcomes such as bleeding in the brain. Assessments include angiography, brain imaging, and clinical evaluations at multiple time points. This ongoing monitoring will help determine which treatment offers better functional recovery and safety for stroke patients with basilar artery occlusion.

Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke