Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT02889562|
Recruitment Status : Completed
First Posted : September 5, 2016
Results First Posted : January 22, 2021
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass Grafting Postoperative Atrial Fibrilation Stroke Systemic Embolism Deep Venous Thrombosis||Drug: Apixaban Drug: Warfarin||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation: a Prospective, Controlled, Randomized Pilot Study|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||May 11, 2019|
|Actual Study Completion Date :||May 11, 2019|
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.
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 Name: 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.
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 Name: Coumadin
- Number of Participants With Strokes [ Time Frame: 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.
- Number of Participants With Thromboembolytic Events [ Time Frame: 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.
- Units of Blood Given After Initiation of Anticoagulation Medication [ Time Frame: 30 days ]Units of blood or blood products given after the first dose of anticoagulation.
- Total Post-operative Length of Stay [ Time Frame: 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.
- Time in Therapeutic Range of INR, if on Warfarin [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889562
|United States, North Dakota|
|Fargo, North Dakota, United States, 58122|
|Principal Investigator:||Cornelius Dyke, MD||Sanford Health|