Improving reperfusion in large vessel ischemic stroke with dornase alfa
Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)
This study is testing if adding a new drug called dornase alfa can help improve blood flow in patients with a severe stroke who are getting standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Melbourne Academic / other |
| Locations | 3 sites (Brisbane, Queensland and 2 other locations) |
| Trial ID | NCT05203224 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of dornase alfa, a recombinant human DNase 1, in improving early reperfusion in patients with acute ischemic stroke who are eligible for standard intravenous thrombolytic therapy. Participants will receive intravenous tenecteplase (or alteplase) and undergo endovascular thrombectomy as part of standard care. The study employs a Bayesian Optimised Phase 2 design to determine the optimal dose of dornase alfa that can lead to substantial reperfusion before thrombectomy. The trial aims to enhance treatment outcomes for patients with major vessel occlusion.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older presenting with acute ischemic stroke eligible for intravenous thrombolytics within 4.5 hours of symptom onset.
Not a fit: Patients with intracranial hemorrhage or rapidly improving symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve reperfusion rates and outcomes for patients suffering from large vessel ischemic strokes.
How similar studies have performed: Previous studies have shown promise in using thrombolytics and thrombectomy for ischemic stroke, but the specific use of dornase alfa in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients presenting with acute ischemic stroke eligible, using standard criteria, to receive IV thrombolytics within 4.5 hours of stroke onset 2. Patient's age is ≥18 years 3. Intention to perform endovascular thrombectomy Imaging inclusion criteria 4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery Exclusion Criteria: 1. Intracranial hemorrhage (ICH) identified by CT or MRI 2. Rapidly improving symptoms at the discretion of the investigator 3. Pre-stroke mRS score of ≥ 4 (indicating previous disability) 4. Hypodensity in \>1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT 5. Contraindication to imaging with contrast agents 6. Any terminal illness such that patient would not be expected to survive more than 1 year 7. 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. 8. Pregnant or lactating women
Where this trial is running
Brisbane, Queensland and 2 other locations
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Not_yet_recruiting)
- Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Bruce CV Campbell, MBBS PhD — University of Melbourne
- Study coordinator: Bruce CV Campbell, MBBS PhD
- Email: bruce.campbell@mh.org.au
- Phone: 0393427000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.