심방세동(SINGLE-AF) 환자의 중간 뇌졸중 위험에 대한 비비타민 칸타고니스트 경구용 항응고제의 효능 및 안전성

간섭 없음: 비항응고제군

2년간 항응고제를 제외한 표준 치료

실험적: 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

의약품: 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

복합 결과

뇌졸중/전신 색전증, 주요 출혈 및 심혈관 사망을 포함한 복합 결과

뇌졸중

허혈성 뇌졸중은 구체적으로 명백한 증상을 동반하는 중추신경계 경색(허혈에 기인한 뇌, 척수 또는 망막 세포사)을 말하며, 정의상 무증상 경색은 알려진 증상을 일으키지 않습니다. 뇌졸중은 또한 광범위하게 뇌내 출혈 및 지주막하 출혈을 포함한다.

주요 출혈

ISTH(International Society on Thrombosis and Haemostasis)/SSC(Scientific and Standardization Committee) 정의 및 출혈 평가 도구는 출혈 증상 보고를 표준화하는 데 유용합니다.

1. 치명적인 출혈. 및/또는 2. 두개내, 척수내, 안구내, 후복막, 관절내 또는 심낭, 또는 구획 증후군을 동반한 근육내와 같은 중요한 부위 또는 기관에서의 증상성 출혈. 및/또는 3. 헤모글로빈 수치가 2g/dL(1.24mmol/L) 이상 떨어지거나 2단위 이상의 전혈 또는 적혈구가 수혈되는 출혈.

전신 색전증

전신 색전증은 동맥 순환의 색전증을 말하며, 말단 장기 관류의 갑작스러운 상실의 임상적 및 객관적 증거 모두에 의해 정의됩니다.

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.