NCT02227550

Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy

An Investigator-driven, Prospective, Parallel-group, Randomised, Open, Blinded Outcome Assessment (PROBE), Multi-centre Trial to Determine the Optimal Anticoagulation Therapy for Patients Untergoing Catheter Ablation of Atrial Fibrillation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 676 (actual)
• Sponsor: Atrial Fibrillation Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study objective is to demonstrate that anticoagulation with the direct factor Xa inhibitor apixaban is not less safe than Vitamin-K-antagonists (VKA) therapy in patients undergoing catheter ablation of non-valvular AF in the prevention of peri-procedural complications. The AXAFA trial will compare peri-ablational treatment with apixaban to peri-ablational treatment wit VKA in a randomized trial of patients undergoing catheter ablation of atrial fibrillation (AF).

Detailed description

AXAFA is an open-label trial designed to evaluate the safety and efficacy of two types of anticoagulant therapy, VKA therapy and therapy with the direct factor Xa inhibitor apixaban, in patients undergoing scheduled catheter ablation for AF. All patients will undergo the ablation procedure after pre-treatment with an anticoagulant (either apixaban in the "Xa group" or a vitamin K antagonist in the "VKA group"). Patients can undergo catheter ablation within the trial after at least 30 days of continuous effective anticoagulation. Ablation can be performed earlier when or timely after exclusion of atrial thrombi have been excluded by a clinically indicated by transthoracic echocardioggram (TEE). After TEE continuous effective anticoagulation must be ensured until the end of the trial. In the MRI-substudy will be explored wether novel oral anticoagulants (NOAC) have the potential to reduce clinically silent brain lesions after catheter ablation of AF.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Vitamin K antagonist	any locally used VKA, INR 2-3, min. 30 days according to aplicable medical guidelines and local clinical routin
DRUG	Apixaban	factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose) dose reduction Apixaban 2,5 mg twice daily in patients who fulfill tow of the following criteria at the time of randomisation: chronic kidney disease (serum creatine \>= 1.5 mg/dl (133mM), \<= 60 kg body weight or age \>= 80 years.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-04-01
• Completion: 2017-09-01
• First posted: 2014-08-28
• Last updated: 2017-10-20

Locations

13 sites across 9 countries: United States, Austria, Belgium, Denmark, Germany, Italy, Netherlands, Spain, United Kingdom