Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy
- Registration Number
- NCT02227550
- Lead Sponsor
- Atrial Fibrillation Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 676
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
General exclusion criteria
E1. Any disease that limits life expectancy to less than 1 year
E2. Participation in another clinical trial, either within the past two months or still ongoing
E3. Previous participation in AXAFA
E4. Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception (oral contraception or intra-uterine device) or sterile women can be randomised.
E5. Breastfeeding women
E6. Drug abuse or clinically manifest alcohol abuse
E7. Any stroke within 14 days before randomisation
E8. Coadministration with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) or strong dual inducers of CYP3A4 and P-gp (Appendix VIII).
Exclusion criteria related to a cardiac condition
E9. Valvular AF (as defined by the focussed update of the ESC guidelines on AF, i.e. severe mitral valve stenosis, mechanical heart valve). Furthermore, patients who underwent mitral valve repair are not eligible for AXAFA.
E10. Any previous ablation or surgical therapy for AF
E11. Cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation
E12. Clinical need for "triple therapy" (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation)
E13. Other contraindications for use of VKA or apixaban
E14. Documented atrial thrombi less than 3 months prior to randomisation.
Exclusion criteria based on laboratory abnormalities
E15. Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) < 15 ml/min
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin K antagonist Vitamin K antagonist VKA group: any Vitamin K antagonist (VKA), INR 2-3 , min. 30 days prescribed as in clinical routine Apixaban Apixaban Xa group: factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method any bleeding event appr. 4 months number
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
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
ACT during ablation during ablation Active clotting measurements
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 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
Trial Locations
- Locations (10)
6 Sites
🇳🇱Different, Netherlands
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research
🇺🇸Austin, Texas, United States
Hospital of the University of Pennsyvlania
🇺🇸Philadelphia, Pennsylvania, United States
Sentara Cariovascular Research Insititute
🇺🇸Norfolk, Virginia, United States
4 Sites
🇬🇧Different, United Kingdom
3 Sites
🇪🇸Different, Spain
13 Sites
🇩🇪Different, Germany
5 Sites
🇩🇰Different, Denmark
Montefiore Medical Center
🇺🇸New York, New York, United States