NCT06241677 Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on DOAC
| NCT ID | NCT06241677 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | CVA (Cerebrovascular Accident) |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2028-12-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2024-04-15 with a primary completion date of 2028-12-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 intravenous thrombolytic therapy (IVT) for acute IS-DOAC. Under the current guideline recommendations, most acute IS-DOAC are contraindicated to IVT (see Intravenous thrombolytic therapy), which resulted in only a small proportion of acute ISDOAC patients being able to receive IVT even if presented early. Nonetheless, our group found that majority of patients had a DOAC level of \<50ng/mL only 24 hours after DOAC cessation (see work done by us), a level deemed clinically negligible and safe for thrombolytic therapy. Together with evolving clinical evidence discussed below, IS-DOAC patients maybe unnecessarily barred from IVT, thus compromised functional recovery. With robust pharmacokinetic and retrospective clinical evidence to support, it is hypothesized that IVT are safe in IS-DOAC patient. The investigators hereby propose a prospective multicenter study to determine the efficacy and safety of IVT in acute IS-DOAC.
Eligibility Criteria
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
Contact & Investigator
Bonaventure Yiu Ming Ip, MB ChB
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06241677 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CVA (Cerebrovascular Accident). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06241677 currently recruiting?
Yes, NCT06241677 is actively recruiting participants. Contact the research team at bonaventureip@cuhk.edu.hk for enrollment information.
Where is the NCT06241677 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06241677 clinical trial?
NCT06241677 is sponsored by Chinese University of Hong Kong. The principal investigator is Bonaventure Yiu Ming Ip, MB ChB at Chinese University of Hong Kong. The trial plans to enroll 260 participants.