Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation (NCT06216769) | Clinical Trial Compass
RecruitingNot Applicable
Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation
South Korea400 participantsStarted 2024-02-01
Plain-language summary
The clinical benefit of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation remains uncertain. We aimed to evaluate the clinical benefit and safety of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation by randomizing into two groups: non-interrupted anticoagulation after the procedure and anticoagulation based on atrial fibrillation recurrence confirmed by implantable loop recorders.
Who can participate
Age range19 Years – 89 Years
SexALL
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Inclusion criteria
✓. Patients who are scheduled to undergo atrial fibrillation catheter ablation due to atrial fibrillation refractory to antiarrhythmic drug treatment.
✓. Patients with non-gender CHA2DS2-VASc score 1-4.
✓. Patients who are taking direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, edoxaban) and further plan taking them life-long to prevent stroke caused by atrial fibrillation.
✓. Patients aged 19-89 (inclusive) who voluntarily sign the informed consent form.
Exclusion criteria
✕. Patients with a stroke/transient ischemic attack history.
✕. 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).
✕. Patients who are contraindicated to anticoagulants other than those listed above.
✕. 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.
✕. Patients with underlying severe anemia (hemoglobin \<8 g/dL at baseline) or a transfusion history within four weeks before visit 1.
✕. Patients with underlying severe thrombocytopenia (platelet count \<50,000/mm3)
What they're measuring
1
Composite of ischemic stroke, transient ischemic attack, other systemic embolism, bleeding (major, clinically relevant), all-cause death