A Phase III Randomized Trial Comparing Intravenous Tenecteplase TNK to Placebo in Adults With Non-Large Vessel Occlusion Ischemic Stroke Treated 4.5 to 12 Hours After Symptoms

What this Trial Is About

Researchers are conducting a phase III, randomized, multi-center clinical trial to evaluate whether intravenous Tenecteplase TNK treatment is better than a placebo for patients who have suffered a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours after they were last seen well. The study focuses on patients with evidence of salvageable brain tissue or a clinical-radiological mismatch on perfusion imaging. The goal is to determine if TNK can improve functional outcomes compared to placebo. Participants will be randomly assigned in a 11 ratio to receive either a single intravenous bolus injection of Tenecteplase at a dose of 0.25 mgkg maximum 25 mg or a placebo bolus injection over 5 seconds. The study uses a double-blind design, and randomization considers factors such as age, stroke severity, and timing since last seen well. The planned enrollment is 466 participants, split evenly between the TNK and placebo groups, with interim analyses to assess study progress. During the 90-day follow-up, participants will undergo assessments including modified Rankin Scale scoring to evaluate functional outcomes, brain imaging to measure infarct volume and reperfusion, and quality of life questionnaires at 3 months, 6 months, and one year. Safety outcomes like intracranial hemorrhage and mortality rates will also be monitored. These evaluations aim to measure the effectiveness and safety of TNK treatment compared to placebo after ischemic stroke.

Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT