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 (AXAFA)

NCT02227550 Phase 4 COMPLETED

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).

Details

Lead sponsor	Atrial Fibrillation Network
Phase	Phase 4
Status	COMPLETED
Enrolment	676
Start date	2014-12
Completion	2017-09

Conditions

• Atrial Fibrillation

Interventions

• Vitamin K antagonist
• Apixaban

Primary outcomes

• death and serious cardiovascular events — appr. 4 months
  A composite of all-cause death, stroke (ischemic stroke, subarachnoid haemorrhage and haemorrhagic stroke), and major bleeding events, def.as BARC 2 or higher

Countries

United States, Austria, Belgium, Denmark, Germany, Italy, Netherlands, Spain, United Kingdom