AcT Trial: Tenecteplase vs Alteplase in Canada
In adult patients with disabling acute ischemic stroke within 4.5 hours eligible for standard thrombolysis, is IV tenecteplase 0.25 mg/kg (single bolus) non-inferior to IV alteplase 0.9 mg/kg for excellent functional outcome (mRS 0-1) at 90-120 days?
Menon BK, et al. (Lancet 2022) · 1577 patients
Population
Included
- Acute ischemic stroke with disabling deficits
- Treatable within 4.5 hours of symptom onset
- Standard IV thrombolysis criteria met per local guidelines
- Age 18 or older
- Aged 18 years or older
- Diagnosis of ischaemic stroke causing disabling neurological deficit
- Presenting within 4.5 h of symptom onset
- Eligible for thrombolysis according to Canadian guidelines (CSBPR 2018)
- Patients also eligible for endovascular thrombectomy were eligible for enrolment
Excluded
- Contraindication to IV thrombolysis per local guidelines
- Hemorrhagic stroke on baseline imaging
- Received tenecteplase or alteplase before enrolment
- Standard contraindications to intravenous thrombolysis as applied under the Canadian Stroke Best Practice Recommendations (CSBPR), for example any source of active haemorrhage or any condition that could increase the risk of major haemorrhage after alteplase administration
- Women known to be pregnant by medical history or investigator examination (could be enrolled only in consultation with an expert stroke physician)
Source: Menon BK, et al., Lancet 2022· Retrieved 2026-06-09
Primary Outcome
Small absolute difference — interpret with caution
mRS 0-1 at 90-120 Days
Study Arms
- Agent
- Tenecteplase
- Dose
- 0.25 mg/kg (max 25 mg)
- Route
- IV
- Frequency
- Single bolus
- Duration
- One-time
- Co-interventions
- Post-treatment care and follow-up imaging per local standards guided by CSBPR; endovascular thrombectomy where clinically indicated
- Agent
- Alteplase
- Dose
- 0.9 mg/kg (max 90 mg)
- Route
- IV
- Frequency
- 0.09 mg/kg bolus, then 60-min infusion of the remaining 0.81 mg/kg
- Duration
- 60 minutes
- Co-interventions
- Post-treatment care and follow-up imaging per local standards guided by CSBPR; endovascular thrombectomy where clinically indicated
Safety
Symptomatic intracranial hemorrhage at 24 hours
3.4%
3.2%
Death within 90 days
15.3%
15.4%
Trial Design
Type
- Pragmatic, multicenter, open-label, registry-linked randomized noninferiority trial
- Tenecteplase 0.25 mg/kg vs alteplase 0.9 mg/kg
- Canadian routine-practice thrombolysis trial across 22 stroke centres
Timeline
Canada; December 2019 to January 2022
N
1577
Enrollment
1,577 patients at 22 stroke centres across Canada. Pragmatic open-label registry-linked RCT. December 2019 to January 2022. Published Lancet 2022.
ClinicalTrials.gov
NCT03889249Bedside Pearl
AcT confirmed tenecteplase 0.25 mg/kg as a practical replacement for alteplase in routine IVT (NI met, RD +2.1 pp). The workflow advantage is the single-bolus administration versus a bolus-plus-infusion for alteplase. Symptomatic ICH rates were similar (3.4% vs 3.2%). Together with TRACE-2 and ATTEST-2, AcT supports the 2026 guideline endorsement of tenecteplase.