Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation



Status:Recruiting
Conditions:Atrial Fibrillation, Cardiology, Cardiology, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:September 2016
End Date:June 2020
Contact:Elizabeth Eidenschink
Email:elizabeth.eidenschink@sanfordhealth.org
Phone:701-234-6298

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Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation: a Prospective, Controlled, Randomized Pilot Study

In this open-label, prospective, randomized pilot study, patients who develop atrial
fibrillation after isolated coronary artery bypass grafting surgery will be identified.
Patients with persistent atrial fibrillation (>12 hours) or recurrent sustained atrial
fibrillation (>2 episodes of atrial fibrillation lasting longer than 30 minutes) will be
candidates for inclusion. Upon meeting study inclusion and exclusion criteria, and after
informed consent, patients will be randomized to either the standard of care (warfarin per
protocol) or apixaban arms of the trial. Routine postoperative care after CABG will occur in
both groups. Upon discharge, anticoagulation in both groups will be managed by the
anticoagulation clinic. Patients will be followed for 30 days after surgery.


Inclusion Criteria:

- Signed Written Informed Consent

- Patients diagnosed with new-onset persistent or recurrent atrial fibrillation after
isolated CABG surgery. Persistent atrial fibrillation is defined as an episode of >12
hours. Recurrent atrial fibrillation is defined as two or more episodes of atrial
fibrillation lasting longer than 30 minutes.

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to
the start of study drug. Patients undergoing isolated CABG must have this tested and
documented prior to the procedure, and this will be verified prior to randomization.

- Women must not be breastfeeding.

- WOCBP must agree to follow instructions for method(s) of contraception for the
duration of treatment with study drug(s): 30 days of treatment plus 5 half-lives of
study drug Apixaban (3 days) or warfarin (8 days) plus 30 days (duration of ovulatory
cycle) for a total of 38 days post-treatment completion.

- Males who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception for the duration of treatment with study drug(s): 30 days
of treatment plus 5 half-lives of study drug Apixaban (3 days) or warfarin (8 days)
plus 90 days (duration of sperm turnover) for a total of 98 days post-treatment
completion.

Exclusion Criteria:

- Atrial fibrillation due to a reversible cause other than recent surgery

- Patients diagnosed with persistent or paroxysmal atrial fibrillation chronically
before undergoing surgery

- Patients with mechanical heart valves

- Patients currently experiencing active bleeding precluding initialization of
anticoagulation therapy in the opinion of their managing physician, or with increased
bleeding risk (as determined by the attending surgeon) believed to be a
contraindication to anticoagulation at the time of randomization Planned major surgery
requiring stoppage of anticoagulation therapy during trial period

- Stroke within the previous 7 days

- Moderate or severe mitral stenosis

- Conditions other than atrial fibrillation that required anticoagulation (prosthetic
mechanical heart valve)

- Patients taking warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, clopidogrel,
ticagrelor, or enoxaparin at home for any indication in the 15 days prior to surgery

- Patients requiring the use of clopidogrel or ticagrelor during the study period

- Severe renal insufficiency (serum creatinine level of >2.5 mg/dL or CrCL<25 ml/min)
for consecutive measurements

- Allergies to warfarin or apixaban, or components of warfarin or apixaban
We found this trial at
1
site
Fargo, North Dakota 58122
Principal Investigator: Cornelius Dyke, MD
Phone: 701-234-6298
?
mi
from
Fargo, ND
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