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 range19 Years
SexALL
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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
✕. 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.
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
✕. 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).