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.
• 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.