NCT02889562

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Sanford Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Bypass Grafting
• Postoperative Atrial Fibrilation
• Stroke
• Systemic Embolism
• Deep Venous Thrombosis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-05-11
• Completion: 2019-05-11
• First posted: 2016-09-05
• Last updated: 2021-01-22
• Results posted: 2021-01-22

Locations

1 site across 1 country: United States