NOR-TEST Trial: Tenecteplase 0.4 mg/kg vs Alteplase
In patients with acute ischemic stroke within 4.5 hours eligible for standard thrombolysis, is IV tenecteplase 0.4 mg/kg superior to IV alteplase 0.9 mg/kg for excellent functional outcome (mRS 0-1) at 3 months?
Logallo N, et al. (Lancet Neurol 2017) · 1100 patients
Population
Included
- Acute ischemic stroke within 4.5 hours
- Standard thrombolysis criteria met
- NIHSS ≥2 (broad eligibility; most enrolled had NIHSS ≤4)
- Age 18 or older
- Suspected acute ischaemic stroke with measurable deficits on the NIHSS
- Admitted within 4.5 h of symptom onset, or within 4.5 h of awakening with symptoms, or eligible for bridging therapy before thrombectomy
- Aged 18 years or older
- Living independently before the stroke
- Judged eligible for intravenous thrombolysis according to Norwegian clinical guidelines
- Patients with symptoms on awakening or unknown onset were included off-label if mismatch between DW-MRI and FLAIR-MRI was detected
Excluded
- Contraindication to thrombolysis
- Hemorrhagic stroke on baseline imaging
- Severe stroke (high NIHSS). Enrolled in small numbers
- Standard contraindications to intravenous thrombolysis as reflected in current Norwegian guideline recommendations
- Inclusion of patients older than 80 years, with minor neurological deficits at presentation, with a previous history of stroke, and with concomitant diabetes mellitus was allowed
Source: Logallo N, et al., Lancet Neurol 2017· Retrieved 2026-06-09
Primary Outcome
Negligible absolute difference
mRS 0-1 at 3 Months
Study Arms
- Agent
- Tenecteplase
- Dose
- 0.4 mg/kg (max 40 mg)
- Route
- IV
- Frequency
- Single bolus
- Duration
- One-time
The 0.4 mg/kg dose tested here is not the contemporary stroke dose. The guideline-endorsed tenecteplase dose is 0.25 mg/kg.
- Agent
- Alteplase
- Dose
- 0.9 mg/kg (max 90 mg)
- Route
- IV
- Frequency
- 10% as initial bolus, then remainder over a 1-h infusion
- Duration
- 60 minutes
Trial Design
Type
- Phase 3, randomized, open-label, blinded-endpoint superiority trial
- Tenecteplase 0.4 mg/kg vs alteplase 0.9 mg/kg
- Included wake-up stroke and bridging patients
Timeline
Norway; September 2012 to September 2016
N
1100
Enrollment
1,100 patients at 13 Norwegian hospitals. Phase 3, open-label, blinded-endpoint superiority RCT. September 2012 to September 2016. Published Lancet Neurol 2017.
ClinicalTrials.gov
NCT01949948Bedside Pearl
NOR-TEST tested tenecteplase 0.4 mg/kg in predominantly mild stroke and found no benefit, but the case mix was too mild to show it even if it existed. The 0.4 mg/kg dose is not used in current practice; guideline-endorsed dose is 0.25 mg/kg. NOR-TEST is historically important context for NOR-TEST 2 Part A (harm signal at 0.4 mg/kg in moderate-severe stroke).