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Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on DOAC

RecruitingNAAges 18 Years - anyAllChinese University of Hong Kong
NCT06241677 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Direct oral anticoagulants (DOAC) have emerged as safe and efficacious ischemic stroke prophylaxis for non-valvular atrial fibrillation (NVAF). All four DOACs - apixaban, dabigatran, edoxaban, rivaroxaban - were associated with lower risks of major bleeding compared to warfarin. Listed as core essential medicines by the World Health Organization, DOAC prescriptions have been surging worldwide. In Hong Kong, approximately 80,000 patients received DOACs from January 2009 through December 2022 according to the Hospital Authority registry. The widespread DOAC usage had created DOAC-specific clinical dilemmas that lack evidence-based treatment despite twenty years of prescribing experience. Ischemic stroke despite DOAC (IS-DOAC), in particular, may occur in up to 6% of DOAC users annually. Due to the in vivo anticoagulation effect, there had been concerns of intracerebral bleeding (ICH) with

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Acute ischemic stroke patients with a last-known-well to presentation time within 4.5 hours 2. Patients who took any doses of apixaban (2.5mg or 5mg twice daily), dabigatran (110mg or 150mg twice daily), edoxaban (30mg or 60mg daily) or rivaroxaban (15mg or 20mg daily) 12-48 hours before presentation 3. National Institute of Health Stroke Scale (NIHSS) ≥ 3 4. Alberta Stroke Programme Early CT (ASPECT) score ≥ 6 5. Pre-morbid modified Rankin Scale (mRS) ≤ 3 6. Patients aged ≥ 18 years old Exclusion Criteria: 1. Initial CT brain showing intracranial haemorrhage 2. Contraindications to IVT according to current guideline recommendations \[5\], except for the use of DOAC within 12-48 hours 3. Patients with an estimated glomerular filtration rate of ≤ 30ml/min/1.73m2 4. Patients with bleeding propensities apart from the use of DOAC, e.g. platelet count of \< 100x109/L 5. Patients with significant head injury immediately prior to presentation
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What it tests

  • alteplase or tenecteplase
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Where

1 site
Chinese University of Hong Kong
Hong Kong, Hong Kong
🤝 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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