NCT07237308

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

A Multicenter Prospective Randomized Study to Evaluate the Efficacy of Apixaban and Clopidogrel on the Prevention of Recurrent Ischemic Stroke in Patients With Atrial Fibrillation and Cerebral Atherosclerosis

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 586 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

"Although oral anticoagulants are effective in preventing cardioembolic stroke in patients with non-valvular atrial fibrillation (NVAF), a considerable proportion of ischemic strokes in these patients are caused by concomitant large artery atherosclerosis. Carotid or intracranial artery stenosis is present in a substantial number of patients with NVAF and is associated with a higher risk of recurrent cerebral infarction despite standard anticoagulation. In such patients, adding an antiplatelet agent to oral anticoagulation may theoretically reduce atherothrombotic events, but it also raises concern for increased bleeding risk. Recent clinical evidence on this issue remains limited, and the optimal antithrombotic strategy for patients with NVAF and coexisting symptomatic atherosclerotic stenosis has not been clearly established. The BEACON-AA trial is a multicenter, randomized, open-label, blinded-endpoint (PROBE) study designed to compare the safety and efficacy of apixaban monotherapy versus apixaban combined with clopidogrel in patients with acute ischemic stroke associated with non-valvular atrial fibrillation (NVAF) and concomitant symptomatic intracranial or extracranial atherosclerosis. Participants will be randomized in a 1:1 ratio to receive apixaban alone or apixaban plus clopidogrel for 30 days, followed by apixaban monotherapy thereafter. Brain MRI including diffusion-weighted and FLAIR sequences will be performed at baseline and at 30 ± 5 days to assess new or recurrent ischemic lesions. The primary efficacy 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. Secondary efficacy outcomes include: 1) incidence of symptomatic ischemic stroke or transient ischemic attack within 90 days, 2) incidence of acute coronary syndrome within 90 days,3) cardiovascular mortality within 90 days, 4) composite major cardiovascular events within 90 days, 5) all-cause mortality within 90 days, 6) proportion of patients with modified Rankin Scale (mRS) 0-2 at 90 days, and 7) proportion of patients with mRS 0-3 at 90 days. The primary safety outcomes are: 1) incidence of major bleeding within 90 days, defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and 2) incidence of new asymptomatic cerebral hemorrhages detected on brain MRI (DWI/FLAIR) at 30 ± 5 days after initiation of study medication. All imaging and clinical events will be independently adjudicated by blinded central adjudication committees."

Conditions

• Stroke
• Ischemic
• Atrial Fibrillation
• Intracrnaial Arterioscelrosis
• Arteriosclerosis

Interventions

Type	Name	Description
DRUG	Apixaban	Apixaban 5mg (or 2.5mg if indicated) once daily. Used as monotherapy or in combination with clopidogrel for 30 days, then continued as monotherapy.
DRUG	Clopidogrel	Clopidogrel 75mg once daily for 30 days in combination with apixaban, then discontinued.

Timeline

• Start date: 2025-12-01
• Primary completion: 2029-07-01
• Completion: 2029-10-01
• First posted: 2025-11-19
• Last updated: 2025-11-19