A Phase 4 interventional study of Apixaban and Clopidogrel in Stroke, Ischemic and Atrial Fibrillation, sponsored by Yonsei University. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Yonsei University · Phase 4, Interventional, and Prevention
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 586 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive apixaban(5mg twice daily, or 2.5mg twice daily if indicated) plus clopidogrel 75mg daily for 30days, followed by apixaban monotherapy thereafter.
Drug: Apixaban
Participants receive apixaban 5mg(or 2.5mg if indicated) twice daily as monotherapy for 30 days and continue apixaban monotherapy thereafter.
Drug: Clopidogrel
Apixaban 5mg(or 2.5mg if indicated) twice daily. Used as monotherapy or in combination with clopidogrel for 30 days, then continued as monotherapy.
Also known as: Eliquis
Clopidogrel 75mg once daily for 30 days in combination with apixaban, then discontinued.
Also known as: Plavix
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.
Time frame: At 30 ± 5 days after initiation of study medication
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
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
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
Composite major cardiovascular events
Composite of ischemic stroke/TIA, acute coronary syndrome, or cardiovascular death.
Time frame: Within 90 days after randomization
All-cause mortality
Death from any cause during the 90-day follow-up period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 30 ± 5 days after randomization
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2029, 36 months after the start.
Of 84 non-industry phase 4 interventional studies under Stroke, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 95. This study's planned 36 months is below that.
Counting every sponsor, half of 90 studies reached it within 57 months; a quarter within 29 and three quarters within 95.
Start moved once since we started tracking on Sep 25, 2026: Dec 2025 → Jul 2026, on Oct 16, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Apixaban