ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632

Recruiting now · Phase 3

Conditions studied: Acute Ischemic Stroke AIS, Stroke Acute, Stroke, Acute, Stroke Ischemic

In brief

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.

Key facts

Study ID

NCT06320431

Run by

University of Calgary

People needed

4000

Starts

2024-09-26

Expected to finish

2030-12-31

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Health Sciences North Horizon Sante-Nord — Greater Sudbury, Ontario, Canada (enrolling)
• McMaster University Hamilton Health Sciences Centre — Hamilton, Ontario, Canada (enrolling)
• University of Calgary — Calgary, Alberta, Canada (enrolling)
• Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (enrolling)
• University of Ottawa — Ottawa, Ontario, Canada (enrolling)
• St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)
• Sunnybrook Health Science Centre — Toronto, Ontario, Canada (enrolling)
• Queen Elizabeth Hospital (PEI) — Charlottetown, Prince Edward Island, Canada (enrolling)
• University of British Columbia — Vancouver, British Columbia, Canada (enrolling)
• Monash University (Box Hill) — Melbourne, Victoria, Australia (enrolling)
• Royal University Hospital — Saskatoon, Saskatchewan, Canada (enrolling)
• University of Manitoba - Winnipeg Health Science Centre — Winnipeg, Manitoba, Canada (enrolling)
• University of Alberta — Edmonton, A, Canada (enrolling)
• Queen Elizabeth II Health Science Center (Halifax) — Halifax, Nova Scotia, Canada
• Medicine Hat Regional Hospital — Medicine Hat, Alberta, Canada
• Red Deer Regional Hospital — Red Deer, Alberta, Canada
• Kelowna Regional Hospital — Kelowna, British Columbia, Canada
• Royal Columbian Hospital — New Westminster, British Columbia, Canada
• Brandon Regional Hospital — Brandon, Manitoba, Canada
• The George Institute for Global Health — Sydney, Barangaroo, Australia
• Kingston General Hospital — Kingston, Ontario, Canada
• Lawson Health Research Institute- London — London, Ontario, Canada
• Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada
• CIUSSS de l'Estrie - CHUS Fleurimont Hôpital (Sherbrooke) — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

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