Health TrialsbyHealthPanel

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

ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-89
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: non-interrupted groupActive comparator 1 intervention
Group B: PIP anticoagulation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to 24 months

Secondary outcomes

1

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

Time frame
up to 24 months
2

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

Time frame
up to 24 months
3

Individual components of the primary endpoint.

Any ischemic stroke, any transient ischemic attack, any systemic embolism, any major bleeding, any clinically relevant non-major bleeding, any death

Time frame
up to 24 months
4

Number of Participants with Myocardial Infarction

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Samjin Pharmaceutical Co., Ltd.

Collaborator

Medtronic

Collaborator

Source ClinicalTrials.gov
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