Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance
NCT04071613 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2021-12-08
Summary
Ischemic stroke is a major health burden globally and in Australia. Treatment for ischemic stroke is time critical and is significantly more effective if administered within the first 90 minutes of symptom onset. This clinical trial will identify if early administration of oral thrombolytic agent, tenecteplase prior to hospital can improve outcomes from stroke, and reduce costs compared to standard care of IV alteplase in hospital
Conditions
- Stroke, Acute, Stroke Ischemic
Interventions
- DRUG
-
Tenecteplase
Route: IV bolus injection Frequency: once only, within 4.5 hours of stroke onset
- DRUG
-
Intravenous tissue plasminogen activator (tPA)
Route: Intravenous (IV) infusion (10% as bolus and the remainder over 60 minutes) Frequency: once only, within 4.5 hours of stroke onset
Sponsors & Collaborators
-
Melbourne Health
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
- 2019-06-20
- Primary Completion
- 2021-11-16
- Completion
- 2021-11-16
Countries
- Australia
Study Locations
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