BEACON-AA: Apixaban With or Without Clopidogrel in Stroke Patients With Atrial Fibrillation and C… (NCT07237308) | Clinical Trial Compass
Not Yet RecruitingPhase 4
BEACON-AA: Apixaban With or Without Clopidogrel in Stroke Patients With Atrial Fibrillation and Cerebral Atherosclerosis
586 participantsStarted 2025-12
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Ability and willingness to provide written informed consent for participation in the study.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of symptomatic or asymptomatic recurrent ischemic lesions detected on brain MRI (DWI/FLAIR)
Timeframe: At 30 ± 5 days after initiation of study medication
. 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).