Comparing different doses of tenecteplase for treating acute ischemic stroke
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 study is testing whether a standard dose or a lower dose of a medication called tenecteplase can help people who have had an acute ischemic stroke recover better and stay safe.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 4000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 24 sites (Sydney, Barangaroo and 23 other locations) |
| Trial ID | NCT06320431 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of standard-dose versus low-dose intravenous tenecteplase in patients with acute ischemic stroke. It employs a randomized, controlled, open-label design with blinded endpoint assessment, enrolling up to 4,000 patients who present to hospitals within 4.5 hours of symptom onset. Participants will be followed for 90 days to assess outcomes related to stroke recovery and safety. The trial also investigates the use of tenecteplase in conjunction with endovascular thrombectomy when necessary.
Who should consider this trial
Good fit: Ideal candidates include patients with disabling acute ischemic stroke who present within 4.5 hours of symptom onset and may benefit from intravenous thrombolysis.
Not a fit: Patients with absolute contraindications for intravenous thrombolysis or those experiencing minor strokes with non-disabling symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to optimized dosing of tenecteplase, improving recovery outcomes for patients with acute ischemic stroke.
How similar studies have performed: Previous studies have shown promising results with tenecteplase, indicating its potential efficacy compared to alteplase, making this approach both relevant and timely.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Consent process completed as per national laws and regulation and the applicable ethics committee requirements. Exclusion Criteria: 1. 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. 2. Minor stroke patients with non-disabling symptoms.
Where this trial is running
Sydney, Barangaroo and 23 other locations
- The George Institute for Global Health — Sydney, Barangaroo, Australia (Not_yet_recruiting)
- Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (Recruiting)
- Monash University (Box Hill) — Melbourne, Victoria, Australia (Recruiting)
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- Medicine Hat Regional Hospital — Medicine Hat, Alberta, Canada (Not_yet_recruiting)
- Red Deer Regional Hospital — Red Deer, Alberta, Canada (Not_yet_recruiting)
- University of Alberta — Edmonton, A, Canada (Recruiting)
- Kelowna Regional Hospital — Kelowna, British Columbia, Canada (Not_yet_recruiting)
- Royal Columbian Hospital — New Westminster, British Columbia, Canada (Not_yet_recruiting)
- University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
- Brandon Regional Hospital — Brandon, Manitoba, Canada (Not_yet_recruiting)
- University of Manitoba - Winnipeg Health Science Centre — Winnipeg, Manitoba, Canada (Recruiting)
- Queen Elizabeth II Health Science Center (Halifax) — Halifax, Nova Scotia, Canada (Not_yet_recruiting)
- Health Sciences North Horizon Sante-Nord — Greater Sudbury, Ontario, Canada (Recruiting)
- McMaster University Hamilton Health Sciences Centre — Hamilton, Ontario, Canada (Recruiting)
- Kingston General Hospital — Kingston, Ontario, Canada (Not_yet_recruiting)
- Lawson Health Research Institute- London — London, Ontario, Canada (Not_yet_recruiting)
- University of Ottawa — Ottawa, Ontario, Canada (Recruiting)
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- Sunnybrook Health Science Centre — Toronto, Ontario, Canada (Recruiting)
- Queen Elizabeth Hospital (PEI) — Charlottetown, Prince Edward Island, Canada (Recruiting)
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Not_yet_recruiting)
- CIUSSS de l'Estrie - CHUS Fleurimont Hôpital (Sherbrooke) — Sherbrooke, Quebec, Canada (Not_yet_recruiting)
- Royal University Hospital — Saskatoon, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Bijoy K Menon, MD — University of Calgary
- Study coordinator: Bijoy K Menon, MD
- Email: bkmmenon@ucalgary.ca
- Phone: 4039448107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.