NCT05203224CompletedPhase 2
Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 330 (actual)
- First submitted
- 10 Jan 2022
- Start date
- 18 Feb 2022
- Primary completion date
- 24 Nov 2025
- Lead sponsor
- University of Melbourne
- Diseases
- Stroke
- NCT number
- NCT05203224
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 330
- From 18 Feb 2022 to the primary completion date, 24 Nov 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-stroke mRS score of ≥ 4 (indicating previous disability)
Other illness
- Intracranial hemorrhage (ICH) identified by CT or MRI
- Any terminal illness such that patient would not be expected to survive more than 1 year
- Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Other
- Rapidly improving symptoms at the discretion of the investigator
- Hypodensity in \>1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT
- Contraindication to imaging with contrast agents
- Pregnant or lactating women
Who the study is looking for
- Patients presenting with acute ischemic stroke eligible, using standard criteria, to receive IV thrombolytics within 4.5 hours of stroke onset
- Patient's age is ≥18 years
- Intention to perform endovascular thrombectomy Imaging inclusion criteria
- Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.