Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)

NCT05203224 PHASE2 RECRUITING

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 (or alteplase due to manufacturer shortage) 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.

Details

Lead sponsor	University of Melbourne
Phase	PHASE2
Status	RECRUITING
Enrolment	300
Start date	Fri Feb 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Dec 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Ischemic Stroke

Interventions

• Dornase Alfa

Countries

Australia