Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation (TASTE) Trial - TASTE

niversity of Newcastle0 sites1,024 target enrollmentFebruary 6, 2017

Overview

No summary available.

Registry

who.int

Start Date

February 6, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Newcastle

•General Inclusion Criteria:
•1\. Patients presenting with acute hemispheric ischaemic stroke eligible using standard criteria to receive IV tPA within 4\.5 hours of stroke onset.
•2\. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
•3\. Patient’s age is \= 18 years.
•Imaging inclusion criteria:
•1\. Vessel occlusion on CT or MR angiography is NOT a requirement for inclusion into the study. However, the presence or absence of ICA occlusion on CT or MR angiography will be required to be noted for randomisation stratification.
•2\. Presence of penumbra \- Using CTP or perfusion MR, mismatch between the perfusion lesion measured on Tmax \> 6 seconds (or Delay Time \> 3 seconds) and the infarct core lesion measured on CTP relative cerebral blood flow (relCBF) or diffusion MR
•a) Mismatch ratio between Tmax (or Delay Time) perfusion lesion and infarct core lesion of \> 1\.8
•b) Penumbra volume \> 15 mL (Tmax or Delay Time lesion volume – infarct core lesion volume)
•3\. Infarct core lesion volume \< 70 mL. Note minimum slice coverage required for CTP will be 80 mm to prevent underestimation of infarct core volume with this modality.

•1\. Intracranial haemorrhage (ICH) identified on baseline CT or MRI.
•2\. Rapidly improving symptoms at the discretion of the investigator.
•3\. Pre\-stroke mRS score of \= 2 (indicating previous disability).
•4\. Participation in any investigational study in the previous 30 days.
•5\. Any terminal illness such that patient would not be expected to survive more than one year.
•6\. Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
•7\. Pregnant women.
•8\. Previous stroke within last three months.
•9\. Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio\-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.
•10\. Current use of vitamin K based oral anticoagulants (e.g. warfarin) and a prolonged prothrombin time (INR \> 1\.5\).