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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
676
any locally used VKA, INR 2-3, min. 30 days according to aplicable medical guidelines and local clinical routin
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.
Montefiore Medical Center
New York, New York, United States
Hospital of the University of Pennsyvlania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
death and serious cardiovascular events
A composite of all-cause death, stroke (ischemic stroke, subarachnoid haemorrhage and haemorrhagic stroke), and major bleeding events, def.as BARC 2 or higher
Time frame: appr. 4 months
any bleeding event
number
Time frame: appr. 4 months
major bleeding events acc. to the ISTH and TIMI definitions
number
Time frame: appr. 4 months
strokes, other systemic embolic events and all-cause death
number
Time frame: appr. 4 month
time from randomisation to ablation
number of days
Time frame: appr. 4 months
nights spent in hospital after ablation
number
Time frame: appr. 4 months
health-care related cost calculation
Time frame: appr. 4 months
hospitalizations for cardiovascular reasons
number
Time frame: appr. 4 months
Treatment duration prior to ablation and total time on oral anticoagulation
number of days
Time frame: appr. 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
Sentara Cariovascular Research Insititute
Norfolk, Virginia, United States
4 Sites
Different, Austria
5 Sites
Different, Belgium
5 Sites
Different, Denmark
13 Sites
Different, Germany
4 Sites
Different, Italy
...and 3 more locations
patients with clinically indicated TEE
number of patients
Time frame: appr. 4 months
ACT during ablation
Active clotting measurements
Time frame: during ablation
recurrent Atrial Fibrillation (AF)
time to recurrent AF
Time frame: appr. 4 months
rhythm status at the end of follow-up
rythm status documented by 24 hour Holter ECG
Time frame: end of follow-up
vascular access complications leading to prolongation of in-hospital stay or specific therapy
number of events
Time frame: appr. 4 months
Quality-of-life changes
questionaire
Time frame: baseline to 3 month follow-up
cognitive function change
questionaire
Time frame: baseline to 3 month follow-up
clinically "silent" MRI-detected brain lesions
prevalence (MRI-substudy)
Time frame: within 48 hours after ablation procedures
Impact of ablation-associated clinically overt strokes or MRI-detected bus clincally "silent" acute brain lesions on cognitive function after ablation
MRI-substudy
Time frame: appr. 4 months