Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation

NCT06216769 | Recruiting DMC

• 1 other identifier: POCKET-OAC
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; direct oral anticoagulant; catheter ablation; implantable loop recorder; continuous cardiac rhythm monitor

Outcome Measures

Primary Outcomes (1)

• Composite of ischemic stroke, transient ischemic attack, other systemic embolism, bleeding (major, clinically relevant), all-cause death

  up to 24 months

Secondary Outcomes (12)

• Composite of thromboembolic events (ischemic stroke, transient ischemic attack, systemic embolism)

  up to 24 months

• Composite of bleeding events events (major bleeding and clinically relevant non-major bleeding)

  up to 24 months

• Individual components of the primary endpoint.

  up to 24 months

• Number of Participants with Myocardial Infarction

  up to 24 months

• Number of Participants with Cardiovascular Death

  up to 24 months

Study Arms (2)

non-interrupted group

ACTIVE COMPARATOR

Anticoagulation is continued regardless of atrial fibrillation recurrence.

Drug: Rivaroxaban

PIP anticoagulation group

EXPERIMENTAL

Anticoagulation continuation will be determined based on the rhythm monitored by ILR. If atrial fibrillation persists more than 6 hours a day, anticoagulation should be started at that point on and continued for four weeks. Anticoagulation can be prescribed even in case of less-than-6-hour cumulative atrial fibrillation burden if the investigator decides that the anticoagulation is necessary.

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

Those in the non-interrupted anticoagulation group, anticoagulation is continued regardless of atrial fibrillation recurrence. Those in the pill-in-the POCKET anticoagulation group will receive direct oral anticoagulation only if they have atrial fibrillation recur over 6 hours.

PIP anticoagulation group; non-interrupted group

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samjin Pharmaceutical Co., Ltd.: collaborator
• Medtronic: collaborator
• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (5)

• Passman R, Leong-Sit P, Andrei AC, Huskin A, Tomson TT, Bernstein R, Ellis E, Waks JW, Zimetbaum P. Targeted Anticoagulation for Atrial Fibrillation Guided by Continuous Rhythm Assessment With an Insertable Cardiac Monitor: The Rhythm Evaluation for Anticoagulation With Continuous Monitoring (REACT.COM) Pilot Study. J Cardiovasc Electrophysiol. 2016 Mar;27(3):264-70. doi: 10.1111/jce.12864. Epub 2015 Nov 23.

  PMID: 26511221 BACKGROUND

• Waks JW, Passman RS, Matos J, Reynolds M, Thosani A, Mela T, Pederson D, Glotzer TV, Zimetbaum P. Intermittent anticoagulation guided by continuous atrial fibrillation burden monitoring using dual-chamber pacemakers and implantable cardioverter-defibrillators: Results from the Tailored Anticoagulation for Non-Continuous Atrial Fibrillation (TACTIC-AF) pilot study. Heart Rhythm. 2018 Nov;15(11):1601-1607. doi: 10.1016/j.hrthm.2018.06.027. Epub 2018 Jul 6.

  PMID: 29981863 BACKGROUND

• Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Purerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16.

  PMID: 20160169 BACKGROUND

• Karasoy D, Gislason GH, Hansen J, Johannessen A, Kober L, Hvidtfeldt M, Ozcan C, Torp-Pedersen C, Hansen ML. Oral anticoagulation therapy after radiofrequency ablation of atrial fibrillation and the risk of thromboembolism and serious bleeding: long-term follow-up in nationwide cohort of Denmark. Eur Heart J. 2015 Feb 1;36(5):307-14a. doi: 10.1093/eurheartj/ehu421. Epub 2014 Nov 3.

  PMID: 25368205 BACKGROUND

• Themistoclakis S, Corrado A, Marchlinski FE, Jais P, Zado E, Rossillo A, Di Biase L, Schweikert RA, Saliba WI, Horton R, Mohanty P, Patel D, Burkhardt DJ, Wazni OM, Bonso A, Callans DJ, Haissaguerre M, Raviele A, Natale A. The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation. J Am Coll Cardiol. 2010 Feb 23;55(8):735-43. doi: 10.1016/j.jacc.2009.11.039.

  PMID: 20170810 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Eue-Keun Choi, MD, PhD

CONTACT

82-2-2072-0688; choiek17@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

KR (1)