EXTEND-IA DNase: Improving early reperfusion with adjuvant dornase alfa in large vessel ischemic stroke

CONDITION

Stroke

GENDER

Both males and females

AGE GROUP

From 18

and above

STATUS

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 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.

CONTACT DETAILS

Clinical Trial Site: Northeast Health Wangaratta (NHW) Clinical Trials Research
Phone Number: 03 5722 5111 Email: clinical.trial@nhw.org.au Location: 35-47 Green Street, Wangaratta VIC, Australia

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Approved By: Melbourne Health Human Research Ethics Committee              

Clinical Trial Registry Link: Click Here