The principle research question is: in patients with acute ischaemic stroke eligible for intravenous (IV) thrombolysis, is tenecteplase superior in efficacy to alteplase, based on functional outcome as assessed by modified Rankin Scale distribution at day 90?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,858
IV Alteplase 0.9mg/kg (max 90mg) bolus + 1h infusion
IV Tenecteplase 0.25mg/kg (max 25mg) single bolus
Queen Elizabeth University Hospital
Glasgow, United Kingdom
modified Rankin Scale
modified Rankin Scale (mRS) at day 90, determined by the Rankin Focused Assessment (RFA) method using centralised telephone interview, analysed by ordinal distribution ("shift") analysis of the scores in intervention and control groups.
Time frame: Day 90 (+/- 7)
Full neurological recovery (modified Rankin Scale 0-1 versus 2-6).
Full neurological recovery (modified Rankin Scale 0-1 versus 2-6).
Time frame: Day 90 (+/- 7)
Independent recovery (modified Rankin Scale score 0-2 versus 3-6).
Independent recovery (modified Rankin Scale score 0-2 versus 3-6).
Time frame: Day 90 (+/- 7)
Early major neurological improvement of 8 or more points, or return to the National Institutes of Health Stroke Scale (NIHSS) total score of 0 or 1 at 24 hour(s).
Early major neurological improvement of 8 or more points, or return to the National Institutes of Health Stroke Scale (NIHSS) total score of 0 or 1 at 24 hour(s).
Time frame: 24 hours
Health Related Quality of Life (EuroQol five dimensions questionnaire, EQ-5D)
Health Related Quality of Life (EuroQol five dimensions questionnaire, EQ-5D)
Time frame: Day 90 (+/- 7)
Barthel Index score
Barthel Index score
Time frame: Day 90 (+/- 7)
Need for thrombectomy
Need for thrombectomy
Time frame: 24 hours
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