Determining the Optimal Dose of Tenecteplase Before Endovascular Therapy for Ischaemic Stroke (EXTEND-IA TNK Part 2)
NCT03340493 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2020-03-04
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 occlusion to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to either 0.4mg/kg or 0.25mg/kg intravenous tenecteplase before all participants undergo endovascular thrombectomy. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.
Conditions
Interventions
- DRUG
-
Tenecteplase
Tenecteplase 0.25mg/kg and 0.4mg/kg are being used
Sponsors & Collaborators
-
The Florey Institute of Neuroscience and Mental Health
collaborator OTHER -
Neuroscience Trials Australia
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-06
- Primary Completion
- 2019-07-23
- Completion
- 2020-02-01
Countries
- Australia
- New Zealand
Study Locations
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