Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)
NCT ID: NCT05203224
Last Updated: 2024-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2022-02-18
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intravenous Dornase alfa (DNase)
Patients will receive a single intravenous dose of dornase alfa (at either 0.125mg/kg, 0.25mg/kg, 0.5mg/kg or 1mg/kg in escalating tiers), administered as a bolus over \~30 seconds.
Dornase Alfa
Intravenous Dornase alfa
Interventions
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Dornase Alfa
Intravenous Dornase alfa
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient's age is ≥18 years
4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of Melbourne
OTHER
Responsible Party
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Principal Investigators
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Bruce CV Campbell, MBBS PhD
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Locations
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Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Di G, Vazquez-Reyes S, Diaz B, Pena-Martinez C, Garcia-Culebras A, Cuartero MI, Moraga A, Pradillo JM, Esposito E, Lo EH, Moro MA, Lizasoain I. Daytime DNase-I Administration Protects Mice From Ischemic Stroke Without Inducing Bleeding or tPA-Induced Hemorrhagic Transformation, Even With Aspirin Pretreatment. Stroke. 2025 Feb;56(2):527-532. doi: 10.1161/STROKEAHA.124.049961. Epub 2025 Jan 27.
Other Identifiers
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MBC2101
Identifier Type: -
Identifier Source: org_study_id
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