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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0005330
Enrollment
2000
Registered
2020-08-24
Start date
2020-09-02
Completion date
Unknown
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Korea University Anam Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Incident rate of stroke or systemic embolism;Incident rate of major bleeding events

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactYun-Gi Kim

Korea University Anam Hospital

tmod0176@gmail.com+82-2-920-5445

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026