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

NCT07237308 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 4-2025-0697
• Study Type: interventional
• Target: 586
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Ischemic; Atrial Fibrillation; Intracrnaial Arterioscelrosis; Arteriosclerosis

Outcome Measures

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.

  At 30 ± 5 days after initiation of study medication

Secondary Outcomes (9)

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

  Within 90 days after randomization

• Incidence of acute coronary syndrome (ACS)

  Within 90 days after randomization

• Cardiovascular mortality

  Within 90 days after randomization

• Composite major cardiovascular events

  Within 90 days after randomization

• All-cause mortality

  Within 90 days after randomization

Study Arms (2)

Apixaban and Clopidogrel Combination Therapy

EXPERIMENTAL

Participants receive apixaban (5 mg or 2.5 mg if indicated) plus clopidogrel 75 mg daily for 30 days, followed by apixaban monotherapy thereafter.

Drug: Apixaban

Apixaban Monotherapy

EXPERIMENTAL

Participants receive apixaban 5 mg (or 2.5 mg if indicated) once daily as monotherapy for 30 days and continue apixaban monotherapy thereafter.

Drug: Clopidogrel

Interventions

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.

Also known as: Eliquis

Apixaban and Clopidogrel Combination Therapy

Clopidogrel DRUG

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

Also known as: Plavix

Apixaban Monotherapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Presence of clinically significant atherosclerosis in the cerebral or aortic arteries, meeting at least one of the following criteria:
• ① ≥30% stenosis in the relevant artery (the artery supplying the infarcted territory) demonstrated by CTA, MRA, or DSA - using the WASID criteria for intracranial arteries and NASCET criteria for extracranial arteries.
• ② High-risk atherosclerotic plaque features in the relevant artery demonstrated by CTA, MRA, or ultrasound, such as ulceration, intraplaque hemorrhage, mobile plaque, or a large lipid core (involving ≥25% of plaque cross-sectional area) on CTA/MRA, or ulceration, mobile plaque, or hypoechoic/echolucent plaque on ultrasound; or presence of branch artery occlusive disease (BAOD).
• ③ Complex aortic plaque (≥4 mm in thickness, mobile, or ulcerative) identified in the ascending aorta or aortic arch by transthoracic/transesophageal echocardiography or coronary CT angiography.
• Ability and willingness to provide written informed consent for participation in the study.

You may not qualify if:

• 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.
• Renal impairment with creatinine clearance ≤30 mL/min/1.73 m².
• Severe hepatic impairment, including acute hepatitis, chronic active hepatitis, hepatic lesions or coagulopathy, hepatic failure, or laboratory evidence of AST/ALT \>2× the upper limit of normal (ULN) or total bilirubin \>1.5× ULN.
• Small-vessel occlusion (lacunar infarction) according to the TOAST classification.
• History within the past 30 days of gastrointestinal bleeding, vascular malformation of the brain or spinal cord, recent brain, spinal, or ophthalmologic surgery or trauma, esophageal varices, or intracranial hemorrhage at any time; or chronic regular use of NSAIDs (≥3 days per week for ≥2 consecutive weeks).
• Ischemic stroke occurring despite concurrent use of both NOAC and antiplatelet therapy.
• Planned surgery or high-bleeding-risk procedure within 3 months, or presence of active bleeding at enrollment.
• Anemia (hemoglobin \< 8.0 g/dL) or thrombocytopenia (platelet count \< 100,000/µL).
• Pre-stroke modified Rankin Scale (mRS) ≥ 2.
• Severe comorbid illness or malignancy not in complete remission with an expected life expectancy \<1 year.
• Known hypersensitivity or allergy to apixaban or clopidogrel.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Stroke; Ischemia; Atrial Fibrillation; Arteriosclerosis

Interventions

apixaban; Clopidogrel

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Young Dae Kim, M.D. Ph.D.

CONTACT

02-2228-1619; NEURO05@YUHS.AC

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: November 19, 2025

Record last verified: 2025-11