Relevant Use of Factor Xa inhibitor in Patients with Non-Valvular Atrial Fibrillation (RESPIRE trial): a multicenter, prospective, non- interventional, observational study

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0005330

Lead Sponsor: Korea University Anam Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 2000

Inclusion Criteria

1)Males and females over 19 years old
2)Patients diagnosed with NVAF
3)Patients with CHA2DS2-VASc score of 1 (2 for females)
* CHA2DS2-VASc score: Assess the risk of stroke up to 9 points by considering the following factors: Congestive heart failure (+1 point), Hypertension (+1 point), Age 75 or over (+2 points), Diabetes mellitus (+1 point), Stroke (+2 points), Transient Ischemic Attack (TIA)/Thromboembolism (TE), Vascular disease (+1 point each), Age 65-74 (+1 point), and Sex (+1 point for females).[6]
4)When the investigator determines that the use of an anticoagulant is necessary to prevent stroke or systemic embolism
5)Patients who have no history of taking medications containing Apixaban within 6 months of screening
6)When the patients who understand the description of this study, agree to participate in the study, and completed/submitted the informed consent form

Exclusion Criteria

1)Patients who are contraindicated according to the precautions for using Apixaban
2)Pregnant and lactating women

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incident rate of stroke or systemic embolism;Incident rate of major bleeding events

Secondary Outcome Measures

Name	Time	Method
Incidence rate of all major bleeding events by each organ;Overall incidence rate and incidence rate by each organ of all bleeding events excluding major bleeding events according to ISTH criteria;All bleeding events according to the HAS-BLED risk score and the number of subjects and incidence rate of major bleeding events;Assessment of Apixaban use pattern (Totoal prescription period and compliance of Apixaban, Change rates of Apixaban dosage and its reasons, Discontinuation rates of Apixaban and its reasons);Incidence rate of final clinical events (Mortality, Transient Ischaemic Attack, Myocardial Infarction, Exacerbation of heart failure);Other adverse events