Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation (AEIOU)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Non-valvular atrial fibrillation, Catheter ablation, Apixaban, Warfarin, Harvard Clinical Research Institute
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent.
- >18 years of age.
- NVAF with planned catheter ablation treatment.
- Planned anticoagulant treatment for at least 1 month after the index procedure.
- Subject agrees to all required follow-up procedures and visits.
For women of childbearing potential (WOCBP):
- Must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.
- Must not be breastfeeding
- Must agree to follow instructions for method(s) of contraception for a total of 33 days post-treatment completion.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a total of 93 days post-treatment completion.
- Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as described in this section.
Exclusion Criteria:
- History of significant bleeding diathesis or coagulopathy or inability to accept blood transfusions.
- Known hypersensitivity or contraindication to heparin or apixaban.
- Subjects with mechanical prosthetic heart valves.
- History of cerebrovascular accident or transient ischemic attach (TIA) within the last 6 months.
- Prior intracranial hemorrhage.
- End-stage renal failure (creatinine clearance rate <15 mL/minute or on dialysis treatment).
- Hepatic disease associated with coagulopathy.
- Current or expected systemic treatment with strong dual inducers of CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort).
- Current or expected systemic treatment with dual antiplatelet therapy, other anticoagulants, or fibrinolytics.
- Planned or expected surgery, or other invasive procedure that would require interruption of anticoagulation within 1 month of the catheter ablation procedure.
- Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or that could impact the scientific integrity of the trial.
- Platelet count ≤100,000/mm3.
- Hemoglobin level <9 g/dL.
- Any active bleeding.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
Sites / Locations
- Site 0020
- Site 0005
- Site 0012
- Site 0011
- Site 0016
- Site 0014
- Site 0018
- Site 0004
- Site 0008
- Site 0001
- Site 0006
- Site 0021
- Site 0019
- Site 0002
- Site 0007
- Site 0009
- Site 0010
- Site 0017
- Site 0003
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Interrupted apixaban
Uninterrupted apixaban
Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.