Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02889562|
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : June 29, 2017
|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)|
|Estimated 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|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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
- Freedom from stroke or thromboembolic event [ Time Frame: 30 days ]
Efficacy will be measured by the freedom from systemic thromboembolism or stroke during the study period. Events relating to thromboembolism or stroke will be adjudicated using pre-determined definitions by independent committee members that remain blinded to the patient's treatment arm.
Safety, including major and minor bleeding will be quantified and defined by the Society on Thrombosis and Haemostasis, as described in section 6.4.2, subsection (2).
- 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.
- Duration from diagnosis of post-operative atrial fibrillation (POAF) to discharge from the hospital [ Time Frame: 30 days ]This will be measured from the time of the EKG that is obtained after AFib is noted on telemetry (confirming the diagnosis of AFib), until hospital discharge. 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
- Patient compliance percentage to apixaban [ Time Frame: 30 days ]compliance percentage to apixaban: measured by asking the patient to bring any unused medication to their 30-day post-operative appointment, where remaining tablets will be counted. This will be calculated as a percentage using the following equation: (# doses prescribed - # of doses not taken and returned to investigator at follow up appointment) / # days prescribed.
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
|Contact: Lora Blackemail@example.com|
|United States, North Dakota|
|Fargo, North Dakota, United States, 58122|
|Contact: Lora Black 605-312-6436 firstname.lastname@example.org|
|Principal Investigator: Cornelius Dyke, MD|
|Sub-Investigator: Todd Chapin, PharmD|
|Principal Investigator:||Cornelius Dyke, MD||Sanford Health|