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BEACON-AA: Apixaban With or Without Clopidogrel in Stroke Patients With Atrial Fibrillation and Cerebral Atherosclerosis

ConditionsStrokeIschemicAtrial FibrillationIntracrnaial ArterioscelrosisArteriosclerosis
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Apixaban

    Drug

    Apixaban 5mg (or 2.5mg if indicated) once daily. Used as monotherapy or in combination with clopidogrel for 30 days, then continued as monotherapy.

  • Clopidogrel

    Drug

    Clopidogrel 75mg once daily for 30 days in combination with apixaban, then discontinued.

Treatment groups

586 Participants
are divided into 2 treatment groups
Group A: Apixaban and Clopidogrel Combination TherapyExperimental treatment 1 intervention
Group B: Apixaban MonotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of symptomatic or asymptomatic recurrent ischemic lesions detected on brain MRI (DWI/FLAIR)

Recurrent ischemic lesions, either symptomatic or asymptomatic, identified on diffusion-weighted imaging (DWI) and FLAIR MRI performed at 30 ± 5 days following randomization.

Time frame
At 30 ± 5 days after initiation of study medication

Secondary outcomes

1

Incidence of symptomatic ischemic stroke or transient ischemic attack (TIA)

Occurrence of new symptomatic ischemic stroke or transient ischemic attack confirmed by clinical and/or imaging criteria.

Time frame
Within 90 days after randomization
2

Incidence of acute coronary syndrome (ACS)

Occurrence of acute coronary syndrome, including unstable angina or myocardial infarction, confirmed by standard diagnostic criteria.

Time frame
Within 90 days after randomization
3

Cardiovascular mortality

Death attributable to cardiovascular causes, including ischemic stroke, myocardial infarction, heart failure, or sudden cardiac death.

Time frame
Within 90 days after randomization
4

Composite major cardiovascular events

Composite of ischemic stroke/TIA, acute coronary syndrome, or cardiovascular death.

Time frame
Within 90 days after randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Source ClinicalTrials.gov

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