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

RecruitingPhase 3Ages 18 Years - anyAllUniversity of Calgary
NCT06320431 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 tenecte

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📋 Eligibility rules (as published)
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.
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What it tests

  • Tenecteplase
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Where

24 sites
The George Institute for Global Health
Sydney, Australia
Royal Prince Alfred Hospital
Sydney, Australia
Monash University (Box Hill)
Melbourne, Australia
University of Calgary
Calgary, Canada
Medicine Hat Regional Hospital
Medicine Hat, Canada
Red Deer Regional Hospital
Red Deer, Canada
University of Alberta
Edmonton, Canada
Kelowna Regional Hospital
Kelowna, Canada

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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