Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05203224




Registration number
NCT05203224
Ethics application status
Date submitted
10/01/2022
Date registered
24/01/2022
Date last updated
24/05/2022

Titles & IDs
Public title
Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)
Scientific title
Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)
Secondary ID [1] 0 0
MBC2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dornase Alfa

Experimental: Intravenous Dornase alfa (DNase) - Patients will receive a single intravenous dose of dornase alfa (at either 0.125mg/kg, 0.25mg/kg, or 0.5mg/kg in escalating tiers), administered as a bolus over ~30 seconds.


Treatment: Drugs: Dornase Alfa
Intravenous Dornase alfa
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients with substantial angiographic reperfusion or absence of retrievable intracranial thrombus at initial angiogram without symptomatic intracerebral hemorrhage
Timepoint [1] 0 0
24 hours post-treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05203224
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bruce CV Campbell, MBBS PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bruce CV Campbell, MBBS PhD
Address 0 0
Country 0 0
Phone 0 0
0393427000
Fax 0 0
Email 0 0
bruce.campbell@mh.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05203224