Comparative efficacy and safety of pill-in-the-pocket anticoagulation strategy

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Subjects must meet all the following criteria:
1. Patients who are scheduled to undergo atrial fibrillation catheter ablation due to atrial fibrillation refractory to antiarrhythmic drug treatment.
2. Patients with non-gender CHA2DS2-VASc score 1-4.
3. Patients who are taking direct oral anticoagulants and further plan taking them life-long to prevent stroke caused by atrial fibrillation.
4. Patients aged 19-89 (inclusive) who voluntarily sign the informed consent form.

Exclusion Criteria

1. Patients with a stroke/transient ischemic attack (TIA) history.
2. Patients with underlying diseases and bleeding findings contraindicated to anticoagulation (e.g., coagulation disorders, bleeding conditions, significant gastrointestinal bleeding within 6 months of enrollment, history of intracranial/intraocular/nontraumatic bleeding, thrombolysis within 48 hours of study enrollment).
3. Patients who are contraindicated to anticoagulants other than those listed above.
4. Patients who are hemodynamically unstable at the time of study enrollment: cardiogenic shock, treatment-unresponsive ventricular arrhythmia, or congestive heart failure (NYHA class IV) at the time of randomization.
5. Patients with underlying severe anemia (hemoglobin <8 g/dL at baseline) or a transfusion history within four weeks before randomization.
6. Patients with underlying severe thrombocytopenia (platelet count <50,000/mm3)
7. Patients is under dialysis or chronic renal failure (creatinine clearance <15ml/min)
8. Patients has severe liver disease (variceal bleeding, ascites, hepatic encephalopathy, or jaundice).
9. Patients has a contraindication to implantation of an ILR (such as limited immunocompetence or a wound-healing disorder).
10. Patient has severe valvular disease (valvular prosthesis, mitral valve repair; however, rheumatic valve disease, regardless of severity, is not eligible for enrollment.).
11. Patient has a non-arrhythmic condition necessitating long-term OAC.
12. Hypertrophic cardiomyopathy
13. Patient is deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease).
14. Patients who are taking warfarin or coumadin.
15. Patients who are taking dual antiplatelet agents (DAPT).
16. Patients with a history of Cox-Maze surgery or atrial fibrillation catheter ablation for atrial fibrillation treatment.
17. Pregnancy or breastfeeding or women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study. *
* Medically acceptable contraceptive includes condom, injectable or implantable contraceptives, intrauterine devices, and oral contraceptives.
18. Patients with a history of malignancy and chemotherapy within the last 1 year
19. Previously received an implantable cardiac electrical device or implantable loop recorder.
20. Previously received a left atrial appendage occlusion or left atrial appendage closure.
21. Patients who are participating in another randomized clinical trial and under follow-up observation.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is defined as a composite of clinical events(ischemic stroke, transient ischemic attack, myocardial infarction, bleeding [major bleeding, clinically relevant bleeding], and all-cause death) that occur within two years of randomization.

Secondary Outcome Measures

Name	Time	Method
The Secondary outcome is defined as a composite of thromboembolic events, a composite of bleeding events, Individual components of the primary outcome, myocardial infarction, cardiovascular death, minor bleeding, a composite of all bleeding events, recurrence of any atrial arrhythmia lasting longer than 2 minutes, atrial arrhythmia burden between 3 and 24 months after catheter ablation, AFEQT and EQ5D questionnaire, change in treatment according to implantable loop recorder results, anticoagulant utilization where the number of days of using anticoagulant from 3 months to 24 months after atrial fibrillation ablation is divided by the total follow-up period.