StrokePhase 4NCT07237308
BEACON-AA: Apixaban With or Without Clopidogrel in Stroke Patients With Atrial Fibrillation and Cerebral Atherosclerosis
A Phase 4 study testing Apixaban and Clopidogrel in people with Stroke and Ischemic, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Ischemic, Atrial Fibrillation
- What is being tested?
- Apixaban and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 586 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2026to Oct 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Uncontrolled diabetes mellitus (HbA1c > 10.0%) or severe hypertension (systolic ≥ 220 mmHg or diastolic ≥ 120 mmHg).
- Concomitant use of strong CYP3A4 and P-glycoprotein inhibitors that can significantly increase apixaban exposure (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin).
- Concomitant use of strong CYP2C19 inducers that can reduce clopidogrel antiplatelet effect (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's wort).
- Clinically significant mass effect due to space-occupying cerebral infarction, or patients expected to require decompressive craniectomy, including those with midline shift > 5 mm, loss of basal cisterns, herniation, fourth-ventricle compression, or obstructive hydrocephalus in posterior fossa infarcts.
- Intracranial hemorrhage or hemorrhagic transformation (PH1 or PH2) according to ECASS criteria.
- Participation in another interventional clinical trial within the past 30 days or concurrent participation in another interventional study (non-interventional observational or registry studies may be allowed at the investigator's discretion).
- Any other condition that, in the investigator's judgment, would make participation or continued involvement in the study inappropriate or infeasible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine
Seoul
Young Dae Kim, Professor, +82-2-2228-1619, NEURO05@YUHS.AC
About this study
Official title: 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
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 new symptomatic or asymptomatic ischemic lesions on DWI/FLAIR at 30 (±5) days compared with baseline MRI, adjudicated by a central committee.
Read the 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 new symptomatic or asymptomatic ischemic lesions on DWI/FLAIR at 30(±5) days compared with baseline MRI, adjudicated by a central committee. 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(MR-Diffusion/FLAIR/SWI (or GRE)) at 30 ± 5 days after initiation of study medication. All imaging and clinical events will be independently adjudicated by blinded central adjudication committees.
- Being tested
- Apixaban, Clopidogrel
- Medical subject headings
- Stroke, Ischemia, Atrial Fibrillation, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
Apixaban 5mg(or 2.5mg if indicated) twice daily. Used as monotherapy or in combination with clopidogrel for 30 days, then continued as monotherapy.
ClopidogrelDrug
Also called Plavix
Clopidogrel 75mg once daily for 30 days in combination with apixaban, then discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban and Clopidogrel Combination Therapy | Experimental | Participants receive apixaban(5mg twice daily, or 2.5mg twice daily if indicated) plus clopidogrel 75mg daily for 30days, followed by apixaban monotherapy thereafter. Receives: Drug: Apixaban |
| Apixaban Monotherapy | Active comparator | Participants receive apixaban 5mg(or 2.5mg if indicated) twice daily as monotherapy for 30 days and continue apixaban monotherapy thereafter. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new symptomatic or asymptomatic ischemic lesions on DWI/FLAIR at 30(±5) days compared with baseline MRI, adjudicated by a central committee
New ischemic lesions, either symptomatic or asymptomatic, identified on DWI/FLAIR at 30 (±5) days compared with baseline MRI, as adjudicated by a central adjudication committee.
Measured: At 30 ± 5 days after initiation of study medication
Secondary outcomes (9)
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.
Measured: Within 90 days after randomization
Incidence of acute coronary syndrome (ACS)
Occurrence of acute coronary syndrome, including unstable angina or myocardial infarction, confirmed by standard diagnostic criteria.
Measured: Within 90 days after randomization
Cardiovascular mortality
Death attributable to cardiovascular causes, including ischemic stroke, myocardial infarction, heart failure, or sudden cardiac death.
Measured: Within 90 days after randomization
Composite major cardiovascular events
Composite of ischemic stroke/TIA, acute coronary syndrome, or cardiovascular death.
Measured: Within 90 days after randomization
All-cause mortality
Death from any cause during the 90-day follow-up period.
Measured: Within 90 days after randomization
Proportion of patients with modified Rankin Scale (mRS) score 0-2
Functional independence defined as mRS score of 0-2 at day 90.
Measured: At 90 days after randomization
Proportion of patients with modified Rankin Scale (mRS) score 0-3
Favorable functional outcome defined as mRS score of 0-3 at day 90.
Measured: At 90 days after randomization
Incidence of major bleeding events according to the ISTH criteria
Major bleeding events defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria, including fatal bleeding, symptomatic intracranial hemorrhage, intraocular bleeding causing vision loss, bleeding resulting in inability to perform usual activities, bleeding requiring transfusion of ≥2 units of whole blood or red cells, or bleeding leading to hospitalization.
Measured: Within 90 days after randomization
Incidence of new asymptomatic cerebral hemorrhages detected on brain MRI(MRiffusion/FLAIR/SWI (or GRE))
Newly developed asymptomatic cerebral hemorrhages identified on MR-Diffusion/FLAIR/SWI(or GRE) performed 30 ± 5 days after randomization.
Measured: At 30 ± 5 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start14 Jul 2026
- Primary completionJul 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 586 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237308
- Sponsor's protocol ID
- 4-2025-0697
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07237308
- Acronym / sponsor ID
- 4-2025-0697
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 586 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 new symptomatic or asymptomatic ischemic lesions on DWI/FLAIR at 30 (±5) days compared with baseline MRI, adjudicated by a central committee.
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 new symptomatic or asymptomatic ischemic lesions on DWI/FLAIR at 30(±5) days compared with baseline MRI, adjudicated by a central committee. 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(MR-Diffusion/FLAIR/SWI (or GRE)) at 30 ± 5 days after initiation of study medication. All imaging and clinical events will be independently adjudicated by blinded central adjudication committees.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban and Clopidogrel Combination Therapy | Experimental | Drug: ApixabanParticipants receive apixaban(5mg twice daily, or 2.5mg twice daily if indicated) plus clopidogrel 75mg daily for 30days, followed by apixaban monotherapy thereafter. |
| Apixaban Monotherapy | Active comparator | Drug: ClopidogrelParticipants receive apixaban 5mg(or 2.5mg if indicated) twice daily as monotherapy for 30 days and continue apixaban monotherapy thereafter. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: EliquisApixaban 5mg(or 2.5mg if indicated) twice daily. Used as monotherapy or in combination with clopidogrel for 30 days, then continued as monotherapy. | Drug | Apixaban and Clopidogrel Combination Therapy |
| ClopidogrelAlso: PlavixClopidogrel 75mg once daily for 30 days in combination with apixaban, then discontinued. | Drug | Apixaban Monotherapy |
Primary outcome
Incidence of new symptomatic or asymptomatic ischemic lesions on DWI/FLAIR at 30(±5) days compared with baseline MRI, adjudicated by a central committee
Time frame: At 30 ± 5 days after initiation of study medication
New ischemic lesions, either symptomatic or asymptomatic, identified on DWI/FLAIR at 30 (±5) days compared with baseline MRI, as adjudicated by a central adjudication committee.
9 secondary outcomes
Incidence of symptomatic ischemic stroke or transient ischemic attack (TIA)
Time frame: Within 90 days after randomization
Incidence of acute coronary syndrome (ACS)
Time frame: Within 90 days after randomization
Cardiovascular mortality
Time frame: Within 90 days after randomization
Composite major cardiovascular events
Time frame: Within 90 days after randomization
All-cause mortality
Time frame: Within 90 days after randomization
Proportion of patients with modified Rankin Scale (mRS) score 0-2
Time frame: At 90 days after randomization
Proportion of patients with modified Rankin Scale (mRS) score 0-3
Time frame: At 90 days after randomization
Incidence of major bleeding events according to the ISTH criteria
Time frame: Within 90 days after randomization
Incidence of new asymptomatic cerebral hemorrhages detected on brain MRI(MRiffusion/FLAIR/SWI (or GRE))
Time frame: At 30 ± 5 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apixaban and Clopidogrel in people with Stroke and Ischemic, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young Dae Kim, M.D. Ph.D. (02-2228-1619, NEURO05@YUHS.AC), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new symptomatic or asymptomatic ischemic lesions on DWI/FLAIR at 30(±5) days compared with baseline MRI, adjudicated by a central committee (time frame: At 30 ± 5 days after initiation of study medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.