BEACON-AA: Apixaban With or Without Clopidogrel in Stroke Patients With Atrial Fibrillation and Cerebral Atherosclerosis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University
About this trial
This trial aims to compare the safety and efficacy of apixaban alone versus apixaban combined with clopidogrel in patients with acute ischemic stroke associated with non-valvular atrial fibrillation and concomitant symptomatic intracranial or extracranial atherosclerosis. Participants will be randomly assigned in a 1:1 ratio to receive apixaban monotherapy or dual therapy with clopidogrel for 30 days. The primary outcome is the incidence of symptomatic or asymptomatic recurrent ischemic lesions detected on brain MRI (DWI/FLAIR) at 30 ± 5 days after initiation of study medication.
Eligibility criteria
Qualifiers
Adults aged 19 years or older at the time of enrollment.
Patients with non-valvular atrial fibrillation (NVAF) documented by electrocardiography or medical records.
Acute ischemic stroke confirmed by brain MRI (diffusion-weighted and FLAIR sequences), with neurological symptoms occurring within 5 days prior to randomization.
Ability and willingness to provide written informed consent for participation in the study.
Disqualifiers
Presence of mechanical heart valves or rheumatic mitral stenosis.
Requirement for antiplatelet agents other than clopidogrel.
Planned percutaneous coronary intervention, coronary artery bypass graft surgery, carotid endarterectomy, or intracranial stenting within 3 months after enrollment.
Presence of mural thrombus in the heart confirmed by imaging.
Trial design
Treatments tested in this trial
- Apixaban
- Clopidogrel
Treatment groups
586 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov