WSO - July 2023 - 754

754
International Journal of Stroke 18(6)
Imaging inclusion criteria include the following:
* Presence of target mismatch on perfusion imaging as
processed by study-approved vendor software,
defined as
{
{
{
penumbra volume >15 mL (perfusion lesion
volume - infarct core volume), and
infarct core volume <70 mL. Note: minimum
slice coverage required for CTP is 80 mm to prevent
underestimation of infarct core volume.
{
volume of severely hypoperfused tissue <100 mL,
defined as tissue with Delay Time >8 s. Large
volumes of severely hypoperfused tissue are
indicative of a poor response to treatment.
* Vessel occlusion on CT or MR angiography is NOT
a requirement for inclusion into the study.
Exclusion criteria include the following:
* intracranial hemorrhage (ICH) identified on baseline
CT or MRI,
* rapidly improving symptoms at the discretion of the
investigator,
* pre-stroke mRS of ⩾2
disability),
(indicating
previous
* participation in any investigational study in the previous
30 days,
* contraindication to thrombolysis,
* any terminal illness such that patient would not be
expected to survive more than 1 year,
* an extracranial or intracranial occlusion where endovascular
therapy can be accessed and delivered
within a rapid time frame, or
* a known hypersensitivity to the active substance
alteplase, tenecteplase, gentamicin or to any of the
excipients.
Randomization
Patients will be randomized to receive tenecteplase or
alteplase. A block randomization procedure will be utilized
to maximize the sequential balance. Patients will be treated
with either alteplase or tenecteplase as per the online randomization
system.
Treatment or intervention
In the TASTE trial, study-eligible patients will be randomized
to tenecteplase, or, alteplase. For alteplase, patients
will receive 0.9 mg/kg up to a maximum of 90 mg, 10% as
bolus and the remainder over 1 h. For tenecteplase, patients
will receive 0.25 mg/kg up to a maximum of 25 mg as a
bolus.
International Journal of Stroke, 18(6)
Sample size estimates
In November 2012, prior to the commencement of TASTE
study, an a priori power analysis was conducted. The study
was initially designed to achieve a power of 90% (twosided
alpha 0.05) to detect a 10% absolute risk difference
between the proportion of patients in tenecteplase and
alteplase groups being disability-free (mRS 0-1) 3 months
after treatment. This resulted in a sample size estimation of
1024 patients (assuming a 5% dropout rate and an alphaspending
function for three interim analyses). The effect
size was based on the phase II tenecteplase trial3 previously
completed by the investigators where half of patients had
an LVO (defined as only the internal carotid artery and
middle cerebral artery to the first segment, M1). As this was
* Proportion of patients with symptomatic ICH (sICH)
as defined by the ECASS III criteria.
* Proportion of patients with mRS 6 at 3 months (death
due to any cause).
* Proportion of patients with mRS 5-6 at 3 months
(severe disability or death).
Data monitoring body
Study monitoring will be managed by the TASTE
Coordinating Centre. Remote and in-person monitoring
will be used for the majority of TASTE sites.
Two safety parameters (deaths and sICH within 36 h of
intervention) will be monitored by the Independent Data
Safety Monitoring Committee (DSMC) after each 100
patients have been enrolled. A recommendation of early
termination due to safety reasons will be considered by the
DSMC if the corresponding Haybittle-Peto boundary
(p = 0.001, Z = 3) at a given interim analysis is crossed.
Primary outcome
The primary outcome of the study is proportion of patients
with mRS 0-1 at 3 months (excellent outcome).
mismatch ratio between perfusion lesion and
infarct core of >1.8,
Secondary outcomes
The secondary outcomes are efficacy and safety:
Efficacy:
* Proportion of patients with mRS 0-2 at 3 months
(good clinical outcome).
* Analysis of mRS across the full ordinal scale at
3 months.
* Proportion of patients achieving a reduction of
NIHSS ⩾ 8 and NIHSS ⩾ 4 or reaching 0-1 at 24 h.
Safety:
WSO - July 2023

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