Testing Intra-arterial Tenecteplase After Mechanical Thrombectomy for Acute Ischemic Stroke with Large Vessel Blockage

What this Trial Is About

Researchers are evaluating the use of intra-arterial tenecteplase given at the end of mechanical thrombectomy in adults with acute ischemic stroke caused by a blockage in a large artery in the brain. This randomized, placebo-controlled trial compares tenecteplase to standard care with a saline placebo to study its safety and effectiveness within 24 hours of stroke symptom onset. The study is a phase 2b3 trial designed to test early neurological improvement and longer-term functional independence in participants. Participants receive either an intra-arterial bolus of tenecteplase dosed by weight maximum 6.25 mg or a placebo saline bolus administered directly at the site of the original artery blockage after thrombectomy. The trial includes two groups with equal chance of assignment and uses a double-blind design. The intervention occurs immediately after thrombectomy, targeting residual clots that may cause ongoing blood flow issues. During the study, participants are monitored for neurological improvement within 24 to 36 hours and functional independence at three months. Additional assessments include brain imaging to measure infarct growth and no-reflow, safety monitoring for bleeding events, mortality rates, and quality of life evaluation. The trial lasts at least three months from randomization, with multiple visits and tests to track outcomes and side effects.

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke