Apixaban in Patients Who Undergo CIED Procedure- Randomized Pilot Study

Study Overview
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Brief Summary
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This study is being done to determine if apixaban is more safe, when compared to warfarin, at reducing the risk of bleeding during CIED procedures.

Official Title
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Evaluate the Safety of Apixaban in Patients Who Undergo Cardiovascular Implantable Electronic Device (CIED) Procedure: A Randomized Pilot Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Apixaban
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Signed informed written consent Patients are taking warfarin or apixaban chronically Patients are at risk of stroke or systemic embolism Patients have NVAF Patients will undergo CIED generator change Age 18-90 Either gender All eligibility criteria must be met Exclusion: Patient is critically ill, or in unstable condition Patient is at high risk for bleeding, HAS-BLED score ≥ 3 Patient is required to take dual antiplatelet agents in addition to anticoagulant drug. (e.g. recent cardiac stent placement) Patients have mechanical cardiac valve or another condition other than NVAF that requires chronic anticoagulation Women of childbearing potential with positive pregnant test Bilirubin >2x upper limit of normal, in association with AST/ALT/ALP >3x upper limit normal Allergy to apixaban and warfarin Subjects requiring taking strong dual inhibitors of CYP3A4 and P-gp who already meet the criteria to take 2.5 mg apixaban Subjects requiring taking strong dual inducers of CYP3A4 and P-gp (.e.g., rifampin, carbamazepine, phenytoin, St. John's wort) Patients who take any investigational drugs within 30 days of enrolling in study. Prisoners or subjects who are involuntarily incarcerated. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Apixaban<br>30 participants prescribed Apixaban 3-14 days before and 28 days after CIED procedure. | Drug: Apixaban<br>* Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change<br>* Other names: Eliquis;|
| Other: Warfarin<br>30 participants will take stable dose of warfarin and go through the procedure without drug interrupt. The dose is adjusted by INR level. Length of treatment is 42 days, 14 days before and 28 days after the procedure. | Drug: Warfarin<br>* Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change<br>* Other names: Coumadin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in the hemoglobin level of 2 g per deciliter or more | Assess the risk of major bleeding when continuing apixaban through the procedure as compared to Warfarin. | 2 months |