Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Interrupted apixaban; Uninterrupted apixaban
Intervention description: 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.; Intervention description: 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.
Intervention MeSH terms: Apixaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial fibrillation; Non-valvular atrial fibrillation; Catheter ablation; Apixaban; Warfarin; Harvard Clinical Research Institute

Summary:

      The purpose of the prospective, randomized cohort in this study is to assess the safety and
      efficacy of 2 apixaban treatment strategies (uninterrupted versus interrupted) in subjects
      planned to undergo catheter ablation for the treatment of non-valvular atrial fibrillation
      (NVAF).

      Simultaneously, a retrospective cohort of 300 warfarin-treated individuals, identified by
      chart review, who are matched to the prospective randomized subjects, will be identified. The
      purpose of the retrospective warfarin cohort is to compare the efficacy and safety of
      warfarin(the current clinical practice) to that of apixaban (uninterrupted, interrupted,
      combined uninterrupted and interrupted).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent.

          2. >18 years of age.

          3. NVAF with planned catheter ablation treatment.

          4. Planned anticoagulant treatment for at least 1 month after the index procedure.

          5. Subject agrees to all required follow-up procedures and visits.

          6. 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.

          7. 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.

          8. 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:

          1. History of significant bleeding diathesis or coagulopathy or inability to accept blood
             transfusions.

          2. Known hypersensitivity or contraindication to heparin or apixaban.

          3. Subjects with mechanical prosthetic heart valves.

          4. History of cerebrovascular accident or transient ischemic attach (TIA) within the last
             6 months.

          5. Prior intracranial hemorrhage.

          6. End-stage renal failure (creatinine clearance rate <15 mL/minute or on dialysis
             treatment).

          7. Hepatic disease associated with coagulopathy.

          8. Current or expected systemic treatment with strong dual inducers of CYP3A4 and
             P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort).

          9. Current or expected systemic treatment with dual antiplatelet therapy, other
             anticoagulants, or fibrinolytics.

         10. Planned or expected surgery, or other invasive procedure that would require
             interruption of anticoagulation within 1 month of the catheter ablation procedure.

         11. 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.

         12. 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.

         13. Platelet count ≤100,000/mm3.

         14. Hemoglobin level <9 g/dL.

         15. Any active bleeding.

         16. Prisoners or subjects who are involuntarily incarcerated.

         17. Subjects who are compulsorily detained for treatment of either a psychiatric or
             physical (e.g., infectious disease) illness.