The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)

Yonsei University

Status and phase: Enrolling; Phase 4

Conditions: Atrial Fibrillation Patients With Intermediate Stroke Risk

Treatments: Drug: Anticoagulation group(Apixaban group)

Study type: Interventional

Funder types: Other

Identifiers

NCT04437654

4-2020-0438

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOAC) in atrial fibrillation patients with intermediate stroke risk (CHA2DS2-VASc score 1 for male, 2 for female).

A. Major safety results include major bleeding and clinically relevant non-major bleeding.

B. Major efficacy results include strokes, systemic embolism and cardiovascular mortality.

C. Other results include myocardial infarction, pulmonary embolism, transient ischemic attack, hospitalization, drug compliance, quality of life questionnaire (AFEQT), cognitive function (KDSQ), aging questionnaire(K-Frail) and hand grip strength.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 19~80 years old
• CHA2DS2-VASc score 1 for male or 2 for female among nonvalvular atrial fibrillation patients
• Patients who agree to register for this study
• Patients who can be observed for the progress after treatment

Exclusion criteria

• Severe liver or kidney dysfunction
• Thyroid dysfunction
• Pregnant or breastfeeding women
• Malignant tumors that have not been completely cured
• Severe structural heart disease
• Predicted survival is less than 12 months
• Patients who do not understand the content of the study or disagree with it

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,800 participants in 2 patient groups

Anticoagulation group(Apixaban group)

Experimental group

Description:

Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years

Treatment:

Drug: Anticoagulation group(Apixaban group)

Nonanticoagulation group

No Intervention group

Description:

Standard treatment except anticoagulant for 2 years