Phase 4 N=300 Randomized Treatment

Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT02608099 ↗

Enrolled (actual)

300

Serious AEs

9.7%

Results posted

Mar 2020

Primary outcome: Primary: Number of Patients With Clinically-Significant Bleeding — 14; 17 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Interrupted apixaban (Drug); Uninterrupted apixaban (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baim Institute for Clinical Research
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Clinically-Significant Bleeding	17; 17	—
PRIMARY Number of Patients With Thrombotic Events	0; 0	—
SECONDARY Number of Patients With Composite of Major Bleeding and Thrombotic Events	3; 2	—
SECONDARY Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events	14; 17	—

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02608099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.