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 range
19 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of ischemic stroke, transient ischemic attack, other systemic embolism, bleeding (major, clinically relevant), all-cause death
. 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)
. The patient is under dialysis or chronic renal failure (creatinine clearance \<15ml/min)
. The patient has severe liver disease (variceal bleeding, ascites, hepatic encephalopathy, or jaundice).