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register hereThe addition of antiplatelet therapy to anticoagulant therapy in patients with stroke with non-valvular atrial fibrillation (NVAF) and atherothrombotic disease may increase bleeding risk without reducing recurrent stroke risk. Aims: To evaluate the clinical benefits of anticoagulant monotherapy compared to combination therapy with anticoagulants and antiplatelet agents.

在此登记在非瓣膜性心房颤动（NVAF）和动脉粥样硬化性血栓性疾病的卒中患者的抗凝治疗中加入抗血小板治疗可能会增加出血风险，而不会降低卒中复发风险。目的：评估抗凝剂单药治疗与抗凝剂和抗血小板药物联合治疗的临床益处。

Methods and design: This is an investigator-initiated prospective multicenter, randomized, openlabel, parallel-group clinical trial. Patients with NVAF and atherothrombotic disease who have had a recent ischemic stroke or transient ischemic attack will be eligible to participate in this trial. Study outcomes: The primary outcome is a composite of ischemic cardiovascular events, including cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, ischemic events requiring urgent revascularization, and major bleeding events within 2 years after randomization.

方法与设计：这是一项由研究者发起的前瞻性多中心，随机，开放标签，平行组临床试验。近期患有缺血性中风或短暂性脑缺血发作的NVAF和动脉粥样硬化血栓性疾病患者将有资格参加该试验。研究结果：主要结果是缺血性心血管事件的综合，包括心血管死亡，缺血性中风，心肌梗塞，全身栓塞，需要紧急血运重建的缺血性事件以及随机化后2年内的主要出血事件。

Sample size estimates: This study will enroll 400 patients, 200 receiving anticoagulant monotherapy and 200 receiving combination therapy. This sample size will provide 90% power (one-sided P=0.025) to detect a risk reduction in outcome events within 2 years, assuming event rates of 13% and 27% for each group, respectively, and a 10% loss to follow-up at a 2.5% significance level with one-sided log-rank tests at an interim analysis and a final analysis.

样本量估计：本研究将招募400名患者，200名接受抗凝单药治疗，200名接受联合治疗。假设每组的事件发生率分别为13%和27%，并且在中期分析和最终分析中以2.5%的显着性水平进行单侧对数秩检验，该样本量将提供90%的功效（单侧P=0.025）来检测2年内结果事件的风险降低。

Discussion: This will be the first study to assess the net clinical benefit of oral anticoagulant monotherapy in ischemic stroke patients with NVAF and atherothrombosis..

讨论：这将是第一项评估口服抗凝剂单药治疗缺血性卒中NVAF和动脉粥样硬化血栓形成患者的净临床益处的研究。。