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

Sponsor
Sanford Health (Other)
Overall Status
Completed
CT.gov ID
NCT02889562
Collaborator
Bristol-Myers Squibb (Industry)
56
Enrollment
1
Location
2
Arms
32.3
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation: a Prospective, Controlled, Randomized Pilot Study
Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
May 11, 2019
Actual Study Completion Date :
May 11, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Apixaban

Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in "dose modifications". The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination.

Drug: Apixaban
Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin.
Other Names:
  • Eliquis

    		•
    Active Comparator: Warfarin

    While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin. After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination.

    Drug: Warfarin
    Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications.
    Other Names:
  • Coumadin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Strokes [30 days]

      Efficacy will be measured by the freedom from stroke during the study period. Events relating to stroke will be adjudicated using pre-determined definitions by independent committee members that remain blinded to the patient's treatment arm.

    2. Number of Participants With Thromboembolytic Events [30 days]

      Efficacy will be measured by the freedom from thromboembolytic events during the study period. Events relating to thromboembolytic events will be adjudicated using pre-determined definitions by independent committee members that remain blinded to the patient's treatment arm.

    Secondary Outcome Measures

    1. Units of Blood Given After Initiation of Anticoagulation Medication [30 days]

      Units of blood or blood products given after the first dose of anticoagulation.

    2. Total Post-operative Length of Stay [30 days]

      This will be measured from the date/time of the end of the subject's surgery until the date/time of the patient's discharge from the hospital. This will be measured in hours, to the nearest tenth of an hour.

    3. Time in Therapeutic Range of INR, if on Warfarin [30 days]

      Time in therapeutic range of INR, if on warfarin, (eg. 2-3), measured as a percentage and defined for each patient using the Rosendaal equation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sanford Health Fargo North Dakota United States 58122

    Sponsors and Collaborators

    • Sanford Health
    • Bristol-Myers Squibb

    Investigators

    • Principal Investigator: Cornelius Dyke, MD, Sanford Health

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Sanford Health
    ClinicalTrials.gov Identifier:
    NCT02889562
    Other Study ID Numbers:
    • CV185-505
    First Posted:
    Sep 5, 2016
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Dec 1, 2020
    Keywords provided by Sanford Health
    apixaban
    anticoagulant
    CABG
    thrombosis
    fibrillation
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Thrombosis
    Embolism
    Venous Thrombosis
    Warfarin
    Apixaban

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Apixaban Warfarin
    Arm/Group Description Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in "dose modifications". The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin. While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin. After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications.
    Period Title: Overall Study
    STARTED 28 28
    COMPLETED 28 26
    NOT COMPLETED 0 2

    Baseline Characteristics

    Arm/Group Title Apixaban Warfarin Total
    Arm/Group Description Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in "dose modifications". The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin. While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin. After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications. Total of all reporting groups
    Overall Participants 28 28 56
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    71.0
    (8.1)
    69.5
    (7.5)
    70.2
    (7.8)
    Sex: Female, Male (Count of Participants)
    Female
    3
    10.7%
    8
    28.6%
    11
    19.6%
    Male
    25
    89.3%
    20
    71.4%
    45
    80.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    28
    100%
    27
    96.4%
    55
    98.2%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    1
    3.6%
    1
    1.8%
    Region of Enrollment (Count of Participants)
    United States
    28
    100%
    28
    100%
    56
    100%
    Weight (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    98.6
    (20.5)
    92.7
    (17.2)
    95.6
    (19.0)
    Body Mass Index (kg/meter-squared) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/meter-squared]
    32.4
    (6.1)
    31.1
    (5.6)
    31.7
    (5.8)

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Strokes
    Description Efficacy will be measured by the freedom from stroke during the study period. Events relating to stroke will be adjudicated using pre-determined definitions by independent committee members that remain blinded to the patient's treatment arm.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Apixaban Warfarin
    Arm/Group Description Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in "dose modifications". The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin. While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin. After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications.
    Measure Participants 28 28
    Number (95% Confidence Interval) [participants]
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Apixaban, Warfarin
    Comments
    Type of Statistical Test Other
    Comments Pearson chi-squared tests or Fisher exact tests
    Statistical Test of Hypothesis p-Value 1.0
    Comments
    Method Chi-squared
    Comments
    2. Primary Outcome
    Title Number of Participants With Thromboembolytic Events
    Description Efficacy will be measured by the freedom from thromboembolytic events during the study period. Events relating to thromboembolytic events will be adjudicated using pre-determined definitions by independent committee members that remain blinded to the patient's treatment arm.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Apixaban Warfarin
    Arm/Group Description Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in "dose modifications". The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin. While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin. After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications.
    Measure Participants 28 28
    Count of Participants [Participants]
    0
    0%
    0
    0%
    3. Secondary Outcome
    Title Units of Blood Given After Initiation of Anticoagulation Medication
    Description Units of blood or blood products given after the first dose of anticoagulation.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    2 units of blood were given per patient
    Arm/Group Title Apixaban Warfarin
    Arm/Group Description Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in "dose modifications". The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin. While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin. After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications.
    Measure Participants 28 28
    Number [total units of blood]
    6
    2
    4. Secondary Outcome
    Title Total Post-operative Length of Stay
    Description This will be measured from the date/time of the end of the subject's surgery until the date/time of the patient's discharge from the hospital. This will be measured in hours, to the nearest tenth of an hour.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Apixaban Warfarin
    Arm/Group Description Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in "dose modifications". The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin. While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin. After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications.
    Measure Participants 28 28
    Mean (Standard Deviation) [hours]
    167.5
    (76.6)
    143.1
    (53.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Apixaban, Warfarin
    Comments
    Type of Statistical Test Other
    Comments t-test and Wilcoxon analysis
    Statistical Test of Hypothesis p-Value 0.17
    Comments
    Method t-test, 1 sided
    Comments
    5. Secondary Outcome
    Title Time in Therapeutic Range of INR, if on Warfarin
    Description Time in therapeutic range of INR, if on warfarin, (eg. 2-3), measured as a percentage and defined for each patient using the Rosendaal equation
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    INR values are not measured for Apixaban. Apixaban is dose adjusted based on renal function, body weight, and age, but Warfarin requires laboratory monitoring due to other factors that may affect therapeutic affects such as prescribed and over-the-counter medications, consumption of alcoholic beverages, or a diet with inconsistent intake of vitamin K content.
    Arm/Group Title Apixaban Warfarin
    Arm/Group Description Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in "dose modifications". The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin. While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin. After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications.
    Measure Participants 0 28
    Mean (Standard Deviation) [percentage]
    56.8
    (22.4)

    Adverse Events

    Time Frame 30 days post-discharge, a total of up to 30 days
    Adverse Event Reporting Description
    Arm/Group Title Apixaban Warfarin
    Arm/Group Description Apixaban is to be dosed at 5 mg by mouth twice daily, except in the case of the criteria listed below in "dose modifications". The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Apixaban: Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin. While patients are hospitalized, warfarin will be dosed daily, with daily INR monitoring per hospital protocol. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin. After discharge from the hospital, warfarin dosing will be subsequently managed by an anticoagulation clinic, per established protocols. All patients will have a goal INR of 2-3 during the duration of the study. The duration of therapy will be at least 30 days. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Warfarin: Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications.
    All Cause Mortality
    Apixaban Warfarin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/28 (0%) 0/28 (0%)
    Serious Adverse Events
    Apixaban Warfarin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/28 (3.6%) 1/28 (3.6%)
    Blood and lymphatic system disorders
    required transfusions after discharge 1/28 (3.6%) 1 0/28 (0%) 0
    Eye disorders
    Subconjunctival hemorrhage 0/28 (0%) 0 1/28 (3.6%) 1
    Other (Not Including Serious) Adverse Events
    Apixaban Warfarin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/28 (50%) 7/28 (25%)
    Blood and lymphatic system disorders
    required transfusions after anticoagulation while in hospital 2/28 (7.1%) 2 1/28 (3.6%) 1
    Gastrointestinal disorders
    GI bleed requiring endoscopy 1/28 (3.6%) 1 0/28 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Required thoracentesis 8/28 (28.6%) 8 6/28 (21.4%) 6
    Vascular disorders
    Epistaxis requiring intervention 2/28 (7.1%) 2 0/28 (0%) 0
    Epistaxis not requiring intervention 1/28 (3.6%) 1 0/28 (0%) 0

    Limitations/Caveats

    Limited by sample size.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Todd Chapin PharmD
    Organization Sanford Health
    Phone 701-417-2351
    Email todd.chapin@sanfordhealth.org
    Responsible Party:
    Sanford Health
    ClinicalTrials.gov Identifier:
    NCT02889562
    Other Study ID Numbers:
    • CV185-505
    First Posted:
    Sep 5, 2016
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Dec 1, 2020