Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
Patients presenting to the emergency department with acute ischemic stroke, who are are
eligible for standard intravenous thrombolytic therapy within 4.5 hours of stroke onset will
be assessed for major vessel occlusion to determine their eligibility for the trial. All
participants will receive intravenous tenecteplase and endovascular thrombectomy as standard
care. The trial is a Bayesian Optimised Phase 2 dose-finding umbrella trial (single arm
versus objective performance criterion of 20% substantial reperfusion prior to endovascular
thrombectomy based on the EXTEND-IA TNK trials NCT02388061, NCT03340493). The aim is to
determine the optimal dose of intravenous dornase alfa (recombinant human DNase 1) with
sufficient promise to take forward in a seamless phase 2b/3 design.