Tenecteplase for Stroke
(ACT-WHEN Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have taken direct oral anticoagulants (DOACs) in the last 24 hours, it may affect how the treatment is administered.
What data supports the effectiveness of the drug Tenecteplase for stroke?
Is tenecteplase generally safe for humans?
How does the drug Tenecteplase differ from other stroke treatments?
What is the purpose of this trial?
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 24 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 (24 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.
Research Team
Bijoy K Menon, MD
Principal Investigator
University of Calgary
Craig Anderson, MD
Principal Investigator
The George Institute
Eligibility Criteria
This trial is for up to 4,000 patients with acute ischemic stroke who are considered for intravenous thrombolysis. It's not clear what the specific inclusion or exclusion criteria are, but typically participants would need a confirmed diagnosis and be within a certain time frame from symptom onset.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous tenecteplase at either standard-dose (0.25 mg/kg) or low-dose (0.18 mg/kg) as a single bolus
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments at Day 90
Extension/Long-term follow-up
Participants may be monitored for additional outcomes and safety measures beyond the initial follow-up period
Treatment Details
Interventions
- Tenecteplase
Tenecteplase is already approved in United States, European Union for the following indications:
- Acute ST elevation myocardial infarction (STEMI)
- Acute myocardial infarction
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
The George Institute for Global Health, Australia
Collaborator