Clinical trial NCT04437654: The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)
Official title: The Efficacy and Safety of Non-vItamiN K antaGonist oraL Anticoagulants for intermEdiate Stroke Risk in Patients With Atrial Fibrillation (SINGLE-AF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atrial Fibrillation Patients With Intermediate Stroke Risk
Keywords: Atrial fibrillation
anticoagulation
intermediate stroke risk
efficacy
safety
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 1800
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite outcome
timeFrame: Baseline
measure: Composite outcome
timeFrame: 1 month
measure: Composite outcome
timeFrame: 6 months
measure: Composite outcome
timeFrame: 12 months
measure: Composite outcome
timeFrame: 18 months
measure: Composite outcome
timeFrame: 24 months
Secondary outcomes:
measure: Stroke
timeFrame: Baseline
measure: Stroke
timeFrame: 1 month
measure: Stroke
timeFrame: 6 months
measure: Stroke
timeFrame: 12 months
measure: Stroke
timeFrame: 18 months
measure: Stroke
timeFrame: 24 months
measure: Systemic embolism
timeFrame: Baseline
measure: Systemic embolism
timeFrame: 1 month
measure: Systemic embolism
timeFrame: 6 months
measure: Systemic embolism
timeFrame: 12 months
measure: Systemic embolism
timeFrame: 18 months
measure: Systemic embolism
timeFrame: 24 months
measure: Major bleeding
timeFrame: Baseline
measure: Major bleeding
timeFrame: 1 month
measure: Major bleeding
timeFrame: 6 months
measure: Major bleeding
timeFrame: 12 months
measure: Major bleeding
timeFrame: 18 months
measure: Major bleeding
timeFrame: 24 months
measure: Clinically Relivant Non-Major Bleeding (CRNMB)
timeFrame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
measure: Death
timeFrame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
measure: Transient ischemic attack (TIA)
timeFrame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
measure: Hospital admission
timeFrame: Baseline, 1month, 6 month, 12 month, 18 month, 24 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital Yonsei University
Study officials:
References: