Status:
RECRUITING
Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Samjin Pharmaceutical Co., Ltd.
Medtronic Korea Co., Ltd.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
19-89 years
Phase:
NA
Brief 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 ant...
Detailed Description
Atrial fibrillation significantly increases the risk of thromboembolic complications, including stroke. Accordingly, current atrial fibrillation treatment guidelines recommend lifelong prescription of...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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).
- The patient has a contraindication to the implantation of an implantable loop recorder (ILR) (such as limited immunocompetence or a wound-healing disorder).
- The patient has severe valvular disease (valvular prosthesis, mitral valve repair; rheumatic mitral stenosis is excluded irrespective of the severity of the disease).
- The patient has a non-arrhythmic condition necessitating long-term oral anticoagulation.
- Hypertrophic cardiomyopathy
- The patient is deemed high risk for non-cardioembolic stroke (i.e. significant carotid artery disease).
- Patients who are taking warfarin or coumadin.
- Patients who are taking dual antiplatelet agents.
- Patients with a history of Cox-Maze surgery or atrial fibrillation catheter ablation for atrial fibrillation treatment.
- Pregnancy, breastfeeding, or women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study. \*
- \* Medically acceptable contraceptives include condoms, injectable or implantable contraceptives, intrauterine devices, and oral contraceptives.
- Known or suspected malignancy with a history of chemotherapy within 1 year.
- The patient has previously implanted cardiac implantable electronic devices or ILR.
- Patients with a history of left atrial appendage occlusion or left atrial appendage closure.
- The patient is participating in another randomized clinical trial and is under follow-up observation.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06216769
Start Date
February 1 2024
End Date
December 31 2030
Last Update
May 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, South Korea