Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT05105633

Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke

Led by University of Melbourne · Updated on 2026-05-06

688

Participants Needed

17

Research Sites

387 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients presenting with posterior circulation ischemic stroke symptoms due to partial or complete basilar artery occlusion within 24 hours from symptom onset or last known well time
  • Age 18 years or older
  • Basilar artery occlusion confirmed by CT Angiography or MR Angiography, considered potentially retrievable
  • Premorbid modified Rankin Scale score of 3 or less
  • Consent obtained according to local legal requirements
Not Eligible

You will not qualify if you...

  • Intracerebral hemorrhage or other diagnoses like tumor on baseline imaging
  • Posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) less than 7
  • Significant cerebellar swelling or acute hydrocephalus
  • Established subacute infarction visible on non-contrast CT
  • Extensive bilateral brainstem ischemia
  • Suspected underlying intracranial atherosclerotic disease or dissection requiring immediate neuro-intervention
  • Premorbid modified Rankin Scale score of 4 or more
  • Standard contraindications to intravenous thrombolysis
  • Contraindications to imaging with contrast agents
  • Clinically evident pregnancy
  • Participation in another investigational drug study
  • Known terminal illness with life expectancy under one year
  • Planned withdrawal of care or comfort measures
  • Any condition posing hazards or interfering with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 17 locations

1

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, Australia

Not Yet Recruiting

2

John Hunter Hospital

Newcastle, New South Wales, Australia

Not Yet Recruiting

3

Liverpool Hospital

Sydney, New South Wales, Australia

Actively Recruiting

4

Gold Coast Hospital

Gold Coast, Queensland, Australia

Not Yet Recruiting

5

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Actively Recruiting

6

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Actively Recruiting

7

Alfred Health

Melbourne, Victoria, Australia

Actively Recruiting

8

Austin Hospital

Melbourne, Victoria, Australia

Actively Recruiting

9

Box Hill Hospital

Melbourne, Victoria, Australia

Actively Recruiting

10

Monash Health

Melbourne, Victoria, Australia

Not Yet Recruiting

11

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Actively Recruiting

12

Western Health

Melbourne, Victoria, Australia

Actively Recruiting

13

Fiona Stanley Hospital

Murdoch, Western Australia, Australia, 6150

Actively Recruiting

14

Grampians Health

Ballarat, Australia

Actively Recruiting

15

Northern Hospital

Melbourne, Australia

Actively Recruiting

16

Hospital Geral de Fortaleza

Fortaleza, Brazil

Actively Recruiting

17

Tours University Hospital

Tours, France

Actively Recruiting

Loading map...

Research Team

F

Fana Alemseged, MD, PhD

CONTACT

E

Erin White

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here