Tenecteplase doses for adults having an acute ischemic stroke
Compares standard and low doses of tenecteplase in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Key facts
- Where
- Brandon, Calgary, Charlottetown, Edmonton, Greater Sudbury, Halifax, Hamilton, Kelowna, Kingston, London, Medicine Hat, Montreal, New Westminster, Ottawa, Red Deer, Saskatoon, Sherbrooke, Toronto, Vancouver, and Winnipeg, CanadaSee the 21 sites
- Phase
- Phase 3
Where in Canada
- Brandon Regional HospitalBrandon, CanadaNot yet recruiting
- University Of CalgaryCalgary, CanadaTaking people
- Queen Elizabeth Hospital (PEI)Charlottetown, CanadaTaking people
- University of AlbertaEdmonton, CanadaTaking people
- Health Sciences North Horizon Sante-NordGreater Sudbury, CanadaTaking people
- Queen Elizabeth II Health Science Center (Halifax)Halifax, CanadaNot yet recruiting
- McMaster University Hamilton Health Sciences CentreHamilton, CanadaTaking people
- Kelowna Regional HospitalKelowna, CanadaNot yet recruiting
- Kingston General HospitalKingston, CanadaNot yet recruiting
- Lawson Health Research Institute- LondonLondon, CanadaNot yet recruiting
- Medicine Hat Regional HospitalMedicine Hat, CanadaNot yet recruiting
- Centre Hospitalier de l'Universite de Montreal (CHUM)Montreal, CanadaNot yet recruiting
- Royal Columbian HospitalNew Westminster, CanadaNot yet recruiting
- Ottawa Hospital Research InstituteOttawa, CanadaTaking people
- Red Deer Regional HospitalRed Deer, CanadaNot yet recruiting
- Royal University HospitalSaskatoon, CanadaTaking people
- CIUSSS de l'Estrie - CHUS Fleurimont Hôpital (Sherbrooke)Sherbrooke, CanadaNot yet recruiting
- St. Michael's HospitalToronto, CanadaTaking people
- Sunnybrook Health Science CentreToronto, CanadaTaking people
- University of British ColumbiaVancouver, CanadaTaking people
- University of Manitoba - Winnipeg Health Science CentreWinnipeg, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Calgary
- Trial code
- NCT06320431
- Record updated
- 21 October 2026
- Original description
This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic stroke (AIS) will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment.Read full original descriptionShow less
A Multicentre, Prospective, Randomized, Open Label, Blinded-endpoint Trial to Optimize the Use of Intravenous Tenecteplase in Participants With Acute Ischemic Stroke (ACT-GLOBAL THROMBOLYSIS (ACT WHEN-001) Within A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL) NCT06352632
This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic stroke (AIS) will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment.
This domain aim is to efficiently, reliably, and simultaneously, determine the comparative effectiveness of intravenous thrombolysis (IVT) using standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) in all patients who present to hospital with acute ischemic stroke and are considered for intravenous thrombolysis. In addition, this domain also seeks to study standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) vs. no TNK upfront with rescue IA TNK if necessary (in those eligible for emergency EVT) and no TNK upfront in those who have taken DOACs during the preceding 48 hours. This domain therefore seeks to generate more robust randomized evidence to guide clinicians in their decisions over the balance of risks and treatment with intravenous thrombolysis with tenecteplase wherever such evidence is currently insufficient.
This domain will currently evaluate four research questions in relation to the use of IVT with tenecteplase:
1. In patients with recent (48 hours) intake of a standard-dose direct oral anticoagulant (DOAC), how should IVT be used? - Use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg) or not at all. 2. In patients planned to be treated with endovascular thrombectomy, how should tenecteplase be used? -Treat with IV tenecteplase (standard- or low-dose) or not at all. 3. In any patient receiving IVT, what is the optimal dose of tenecteplase? - use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg). 4. To what extent is the treatment effect of standard- vs. low-dose tenecteplase modified by key patient characteristics, such as diabetes, prior antiplatelet therapy, renal failure, or frailty, old age or having a heavy burden of cerebral small vessel disease on brain imaging.
Inclusion: All patients with disabling AIS presenting within 4.5 hours of symptom onset or last known well who may benefit from intravenous thrombolysis (IVT) with tenecteplase. Patients potentially eligible for IVT with conditions described as relative contraindications in national guidelines where physician discretion is recommended are eligible. Patients who received a DOAC, and those planned for emergency EVT are eligible; Consent process completed as per national laws and regulation and the applicable ethics committee requirements.
Exclusion: Any absolute contraindication for IV thrombolysis per current national guidelines. Examples include those who are actively bleeding, had recent intracranial surgery, head trauma, intracranial or subarachnoid hemorrhage, or a bleeding diathesis; Minor stroke patients with non-disabling symptoms.