Atrial Fibrillation study: Rivaroxaban
Official title Pill-in-the-POCKET Oral Anticoagulation Strategy After AF Catheter Ablation
ClinicalTrials.gov ID: NCT06216769
What this study is testing
What is Rivaroxaban?
Rivaroxaban is an investigational medicine, taken by mouth, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The clinical benefit of pill-in-the-POCKET anticoagulation after atrial fibrillation catheter ablation remains uncertain.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 89
You may be able to join 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...
- Patients aged 19-89 (inclusive) who voluntarily sign the informed consent form.
You likely can't join 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...
- 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...
- 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)
See the full eligibility 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.
- 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...
- 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.
- Pregnancy, breastfeeding, or women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study.
- 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 assigned by chance clinical trial and is under follow-up observation.
The study team makes the final eligibility decision.
Where it is enrolling
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seoul, South Korea. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.