Status:
COMPLETED
Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance
Lead Sponsor:
Melbourne Health
Conditions:
Stroke, Acute, Stroke Ischemic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 sy...
Detailed Description
Currently, alteplase is the standard clot-dissolving therapy for ischemic stroke, however this treatment is only effective in 30-45% of patients. Importantly, treatment of ischemic stroke is more effe...
Eligibility Criteria
Inclusion
- Patients being attended by the mobile stroke unit with an acute ischemic stroke eligible for thrombolysis using standard clinical and CT criteria.
- Patient's age is ≥18 years
- Premorbid mRS \<4
Exclusion
- Intracranial hemorrhage (ICH) or other diagnosis (e.g. tumor) identified by CT on the MSU
- Hypodensity in \>1/3 MCA territory or equivalent proportion of ACA or PCA territory on non-contrast CT on MSU
- Pre-stroke mRS score of \> 3 (indicating significant previous disability)
- 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.
- Rapidly improving symptoms.
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2021
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04071613
Start Date
June 20 2019
End Date
November 16 2021
Last Update
December 8 2021
Active Locations (5)
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1
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
2
Eastern Health
Melbourne, Victoria, Australia
3
Western Hospital
Melbourne, Victoria, Australia
4
Alfred Hopsital
Melbourne, Australia