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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/NCT05105633




Registration number
NCT05105633
Ethics application status
Date submitted
21/10/2021
Date registered
3/11/2021
Date last updated
6/12/2023

Titles & IDs
Public title
Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke
Scientific title
Extending the Time Window for Tenecteplase by Effective RecanalizatioN of bAsilar Artery occLusion in Patients With POSTerior Circulation Stroke (POST-ETERNAL)
Secondary ID [1] 0 0
CT21028
Universal Trial Number (UTN)
Trial acronym
POST-ETERNAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basilar Artery Occlusion 0 0
Condition category
Condition code
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 - Tenecteplase
Treatment: Drugs - Standard Care (which may include intravenous Alteplase)

Experimental: Intravenous tenecteplase (TNK) - Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds).

Active Comparator: Standard Care (which may include intravenous Alteplase) - Patients will receive standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as a bolus and the remainder as an infusion over 1 hour).


Treatment: Drugs: Tenecteplase
Genetically modified tissue plasminogen activator at a dose of 0.25mg/kg given as an intravenous bolus over 5-10 seconds.

Treatment: Drugs: Standard Care (which may include intravenous Alteplase)
Patients will receive standard care which may include intravenous alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as a bolus and the remainder as an infusion over 1 hour.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Rankin Scale (mRS) 0-1 or return to baseline mRS at 90 days
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Modified Rankin Scale 0-2 or return to baseline mRS at 90 days
Timepoint [1] 0 0
90 days
Secondary outcome [2] 0 0
Modified Rankin Scale 0-3 or return to baseline mRS at 90 days
Timepoint [2] 0 0
90 days
Secondary outcome [3] 0 0
Ordinal analysis of the mRS at 90 days
Timepoint [3] 0 0
90 days
Secondary outcome [4] 0 0
Early clinical improvement
Timepoint [4] 0 0
72 hours
Secondary outcome [5] 0 0
Substantial reperfusion on initial digital subtraction angiography run prior to thrombectomy
Timepoint [5] 0 0
Initial angiogram (day 0)
Secondary outcome [6] 0 0
Quality of Life assessment (EQ-5D) - at 90 days and 12 months
Timepoint [6] 0 0
90 days and 12 months
Secondary outcome [7] 0 0
Symptomatic intracerebral hemorrhage (sICH)
Timepoint [7] 0 0
36 hours
Secondary outcome [8] 0 0
All-cause mortality within 90 days
Timepoint [8] 0 0
90 days
Secondary outcome [9] 0 0
Modified Rankin Scale (mRS) 5-6 at 90 days
Timepoint [9] 0 0
90 days

Eligibility
Key inclusion criteria
- Patients presenting with posterior circulation ischemic stroke symptoms due to partial
or complete basilar artery occlusion within 24 hours from symptom onset (or clinical
deterioration/coma) or the time the patient was last known to be well.

- Patient's age is =18 years

- Presence of basilar artery occlusion, proven by CT Angiography or MR Angiography.
Basilar artery occlusion is defined as 'potentially retrievable' occlusion at the
basilar artery. This can be a partial or complete occlusion.

- Premorbid mRS =3 (independent function or requiring only minor domestic assistance and
able to manage alone for at least 1 week).

- Local legal requirements for consent have been satisfied.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Intracerebral hemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline
imaging.

- Posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) <7 on
non-contrast CT, CT Angiography source images or DWI MRI.

- Significant cerebellar mass effect or acute hydrocephalus.

- Established frank hypodensity on non-contrast CT indicating subacute infarction.

- Bilateral extensive brainstem ischemia.

- Strong suspicion of underlying intracranial atherosclerotic disease (e.g diffuse
arterial calcifications, basilar stenosis) or dissection which may require immediate
neuro-interventional procedure with intracranial stenting and not benefit from
intravenous thrombolysis at investigator's discretion.

- Pre-stroke mRS of =4 (indicating moderate to severe previous disability).

- Other standard contraindications to intravenous thrombolysis.

- Contraindication to imaging with contrast agents.

- Clinically evident pregnant women.

- Current participation in another research drug treatment protocol.

- Known terminal illness such that the patients would not be expected to survive a year.

- Planned withdrawal of care or comfort care measures.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 2/Phase 3
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
29/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
688
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [3] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [4] 0 0
Gold Coast Hospital - Gold Coast
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Alfred Health - Melbourne
Recruitment hospital [8] 0 0
Austin Hospital - Melbourne
Recruitment hospital [9] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [10] 0 0
Monash Health - Melbourne
Recruitment hospital [11] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [12] 0 0
Western Health - Melbourne
Recruitment hospital [13] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Newcastle
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Gold Coast
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
- Melbourne
Recruitment postcode(s) [8] 0 0
6150 - Murdoch

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 an acute ischemic stroke due to basilar
artery occlusion within 24 hours of stroke onset will be assessed to determine their
eligibility for randomization into the trial. If the patient gives informed consent they will
be randomised 50:50 using a central computerised allocation process to either standard of
care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg) or
tenecteplase 0.25mg/kg before undergoing mechanical thrombectomy as required at treating
clinician's discretion. The trial is Multi-arm, Multi-stage, prospective, randomised,
open-label, blinded endpoint (PROBE) design with seamless phase 2b/3 transition if the
intermediate endpoint (recanalization without symptomatic intracerebral hemorrhage) is met in
analysis of the first 202 patients. Adaptive sample size re-estimation (Mehta and Pocock)
will be performed when 240 patients have completed 3 month follow-up (minimum sample size
320, maximum sample size 688).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05105633
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bruce Campbell
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
Fana Alemseged, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+6193424424
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05105633