Efficacy and Safety of Injection Tenecteplase in 4.5 to 24 hours imaging eligible window patients with Acute Ischemic Stroke (EAST-AIS) (P7-5.016)

Abstract

<h3>Objective:</h3> To determine the efficacy and safety of injection Tenecteplase along with standard treatment in acute ischemic stroke with or without large vessel occlusion presenting within 4.5 to 24 hours of onset <h3>Background:</h3> Currently in Acute Ischemic stroke (AIS) patients, intravenous thrombolysis is approved for the 0-to-4.5-hour window period and mechanical thrombectomy for large vessel occlusion up to 24 hours of stroke onset in eligible patients. Previous studies have evaluated the safety and efficacy of Tenectplasse in a small number of patients in the period beyond 4.5hours of stroke onset. In the present study, we evaluate the safety and efficacy of injction of Tenectplase in AIS patients (with or without large vessel occlusion) in the time window 4.5 to 24 hours of stroke onset. <h3>Design/Methods:</h3> Patients will be enrolled primarily based on imaging the eligibility criteria with a perfusion lesion-ischemic core mismatch greater than1.8 between the volume of hypoperfusion and the volume of the ischemic core, with the absolute difference in volume being greater than 10 ml, and ischemic-core volume less than 70 ml. Additional inclusion criteria are patients age should be &gt; 18 years, onset period between 4.5 to 24 hours with NIHSS&gt;5, and pre-stroke Mrs value of 2 or less. A total of one hundred patients are planned to be enrolled, 50 each in Tenectlase are (cases-0.25mg/kg; maximum 25mg) and placebo arm (controls) in a ratio of 1:1 administered as a singlr bolus injection. An independent data safety and monitoring board (DSMB) will share responsibility for regular oversight of patient safety during the study. <h3>Results:</h3> This is ongoing randomized control trial. <h3>Conclusions:</h3> The study is an investigator initiated prospective and randomized controlled trial design. The safety endpoints along with efficacy of Tenecteplase using the modified Ranking Scale (mRS) score at 90 days of stroke onset will be determined. <b>Disclosure:</b> Dr. Jatwani has nothing to disclose. Awadh K. Pandit has nothing to disclose. Ms. Tangri has nothing to disclose. Dr. Srivastava has nothing to disclose. Dr. Bhatia has nothing to disclose. Ajay Garg has nothing to disclose. Dr. Vibha has nothing to disclose. Vishnu VY has nothing to disclose. Dr. Das has nothing to disclose. Divya MR has nothing to disclose.