Status:
COMPLETED
Determining the Optimal Dose of Tenecteplase Before Endovascular Therapy for Ischaemic Stroke (EXTEND-IA TNK Part 2)
Lead Sponsor:
Neuroscience Trials Australia
Collaborating Sponsors:
The Florey Institute of Neuroscience and Mental Health
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients presenting to the emergency department with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be assessed for major vessel oc...
Detailed Description
The study will be a multicentre, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 2 trial (2 arm with 1:1 randomization) in ischemic stroke patients. Randomized patien...
Eligibility Criteria
Inclusion
- Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset
- Patient's age is ≥18 years
- Arterial occlusion on CTA (computed tomography angiography) or MRA (Magnetic Resonance Angiography) of the ICA, M1, M2 or basilar artery.
Exclusion
- Intracranial hemorrhage (ICH) identified by CT or MRI
- Rapidly improving symptoms at the discretion of the investigator
- Pre-stroke mRS score of ≥ 4 (indicating previous disability)
- Hypodensity in \>1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT
- Contra indication to imaging with contrast agents
- Any terminal illness such that patient would not be expected to survive more than 1 year
- 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.
- Pregnant women
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03340493
Start Date
December 6 2017
End Date
February 1 2020
Last Update
March 4 2020
Active Locations (28)
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1
Albury Hospital
Albury, New South Wales, Australia, 2640
2
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia, 2200
3
Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
4
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050