非维生素 K 拮抗剂口服抗凝剂对心房颤动 (SINGLE-AF) 患者中度卒中风险的疗效和安全性

无干预：非抗凝组

除抗凝剂外的标准治疗 2 年

实验性的：Anticoagulation group(DOAC group)

Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) or rivaroxaban 20mg once daily (15mg once daily if meets dose-reduction criteria) for 2 years

药品：Anticoagulation group(DOAC group)

Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) or rivaroxaban 20mg once daily (15mg once daily if meets dose-reduction criteria) for 2 years

综合结果

综合结果，包括中风/系统性栓塞，重度出血和心血管死亡

中风

缺血性中风特指伴有明显症状的中枢神经系统梗塞（大脑、脊髓或因缺血引起的视网膜细胞死亡），而根据定义，无症状梗塞不会引起已知症状。 中风还广泛地包括脑内出血和蛛网膜下腔出血。

大出血

国际血栓形成与止血学会 (ISTH)/科学与标准化委员会 (SSC) 的定义和出血评估工具有助于出血症状报告的标准化。

1.致命性出血。 和/或 2. 关键区域或器官的症状性出血，如颅内、脊柱内、眼内、腹膜后、关节内或心包，或肌内伴筋膜室综合征。 和/或 3. 出血导致血红蛋白水平下降 2 g/dL (1.24 mmol/L) 或更多，或导致输注两个或更多单位的全血或红细胞。

全身性栓塞

全身性栓塞是指动脉循环中的栓塞，由终末器官灌注突然丧失的临床和客观证据来定义。

Cardiovascular Death

Death due to myocardial infarction, sudden cardiac death, heart failure, stroke, cardiovascular procedures, cardiovascular hemorrhage, and any case of death in which a cardiovascular cause cannot be excluded as adjudicated by a clinical events committee.

Clinically Relevant Non-Major Bleeding (CRNMB)

1. Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: i. requiring medical intervention by a healthcare professional ii. leading to hospitalization or increased level of care iii. prompting a face to face (i.e., not just a telephone or electronic communication) evaluation 2. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1: i. Fatal bleeding, and/or ii. Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or iii. Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells.

Death

The permanent stopping of all the vital bodily activities

Transient ischemic attack (TIA)

TIA is brief episodes of neurological dysfunction resulting from focal cerebral ischemia not associated with permanent cerebral infarction.

Myocardial infarction

The definition of myocardial infarction (MI) was based on the Third Universal MI definition

Hospital admission

Hospital admission means admission of a covered person to a hospital as an inpatient for medically necessary and appropriate care and treatment of an Illness or Injury.