Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on DOAC

Recruiting now · Not applicable

Conditions studied: CVA (Cerebrovascular Accident)

In brief

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.

Key facts

Study ID: NCT06241677
Run by: Chinese University of Hong Kong
People needed: 260
Starts: 2024-04-15
Expected to finish: 2029-03-31
Last updated by the study team: 2026-02-24

Who can join

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

You may qualify if…

Acute ischemic stroke patients with a last-known-well to presentation time within 4.5 hours
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
National Institute of Health Stroke Scale (NIHSS) ≥ 3
Alberta Stroke Programme Early CT (ASPECT) score ≥ 6
Pre-morbid modified Rankin Scale (mRS) ≤ 3
Patients aged ≥ 18 years old

You may not qualify if…

Initial CT brain showing intracranial haemorrhage
Contraindications to IVT according to current guideline recommendations [5], except for the use of DOAC within 12-48 hours
Patients with an estimated glomerular filtration rate of ≤ 30ml/min/1.73m2
Patients with bleeding propensities apart from the use of DOAC, e.g. platelet count of < 100x109/L
Patients with significant head injury immediately prior to presentation

Where it is running

Chinese University of Hong Kong — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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