Ischemic Stroke Clinical Trial
Official title:
Randomised Trial of Tenecteplase vs. Alteplase for Recanalisation in Acute Ischemic Stroke
BACKGROUND: Alteplase dissolves blood vessel clots in acute ischemic stroke and is the only
approved acute drug treatment <4½ hours of stroke onset. The overall benefit from alteplase
is substantial, but up to 2/3 of patients with large artery clots may not achieve reopening
of the vessel and up to 40% of the patients may remain severely disabled or die, leaving
substantial room for improvement. Tenecteplase, widely used in coronary heart disease, may
be more effective and may have less bleeding complications than alteplase, and may be the
drug of choice also in stroke.
HYPOTHESIS: Tenecteplase may be given safely to patients with acute ischemic stroke at a
dose that is associated with improved clinical outcome compared with existing treatment
options.
AIMS: To compare efficacy and safety of tenecteplase vs. alteplase given <4½ hours after
symptom onset.
STUDY ENDPOINTS: The primary study endpoint is excellent clinical outcome at 3 months
(effect). Secondary study endpoints are major early clinical improvement (effect) and
bleeding complications (safety).
HYPOTHESIS: 1) Tenecteplase 0.4 mg/kg may be given safely to patients with acute ischaemic
stroke <4½ hours after stroke onset. 2) Tenecteplase 0,4 mg/kg (single bolus)has superior
efficacy and safety compared with alteplase 0.9 mg/kg (10% bolus + 90% infusion/60 minutes)
when given within 4 ½ hours after stroke onset.
DESIGN: NOR-TEST is a multi-centre PROBE (prospective randomised, open-label, blinded
endpoint) trial with randomisation tenecteplase:alteplase 1:1.
POWER CALCULATION: NOR-TEST aims at detecting a 9 % higher percentage excellent outcome with
tenecteplase vs. alteplase (r1=0.40; r2=0.49; OR 1.44; power 0.8), and will include 954
patients during 3 years.
PATIENT RECRUITMENT: All patients found eligible for thrombolytic therapy are eligible for
NOR-TEST, i.e. NOR-TEST changes neither inclusion nor exclusion criteria. The number of
patients treated at a participating centre will therefore essentially remain unchanged.
Estimated 400 patients are thrombolysed per year in participating centres. Allowing for 20%
of patients not being included in NOR-TEST, the total number of patients (n=954) will still
be met.
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