Atrial Fibrillation
Conditions
Keywords
Atrilal fibrillation, anticoagulation, prevention of peri-procedural complication, catheter ablation
Brief 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.
Interventions
any locally used VKA, INR 2-3, min. 30 days according to aplicable medical guidelines and local clinical routin
DRUGApixaban
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.
Sponsors
Bristol-Myers Squibb
Pfizer
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Atrial Fibrillation Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
I1. Non-valvular AF (ECG-documented) with a clinical indication for catheter ablation I2. Clinical indication to undergo catheter ablation on continuous anticoagulant therapy I3. Presence of at least one of the CHADS2 stroke risk factors * Stroke or TIA * age ≥ 75 years, * hypertension, defined as chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure \> 145/90 mm Hg, * diabetes mellitus, * symptomatic heart failure (NYHA ≥ II). I4. Age ≥ 18 years I5. Provision of signed informed consent
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| major bleeding events acc. to the ISTH and TIMI definitions | appr. 4 months | number |
| strokes, other systemic embolic events and all-cause death | appr. 4 month | number |
| time from randomisation to ablation | appr. 4 months | number of days |
| nights spent in hospital after ablation | appr. 4 months | number |
| health-care related cost calculation | appr. 4 months | — |
| hospitalizations for cardiovascular reasons | appr. 4 months | number |
| Treatment duration prior to ablation and total time on oral anticoagulation | appr. 4 months | number of days |
| patients with clinically indicated TEE | appr. 4 months | number of patients |
| any bleeding event | appr. 4 months | number |
| recurrent Atrial Fibrillation (AF) | appr. 4 months | time to recurrent AF |
| rhythm status at the end of follow-up | end of follow-up | rythm status documented by 24 hour Holter ECG |
| vascular access complications leading to prolongation of in-hospital stay or specific therapy | appr. 4 months | number of events |
| Quality-of-life changes | baseline to 3 month follow-up | questionaire |
| cognitive function change | baseline to 3 month follow-up | questionaire |
| clinically silent MRI-detected brain lesions | within 48 hours after ablation procedures | prevalence (MRI-substudy) |
| Impact of ablation-associated clinically overt strokes or MRI-detected bus clincally silent acute brain lesions on cognitive function after ablation | appr. 4 months | MRI-substudy |
| ACT during ablation | during ablation | Active clotting measurements |
Countries
Austria, Belgium, Denmark, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Outcome results
None listed