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

Completed · Phase 4

Conditions studied: Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT02227550

Run by

Atrial Fibrillation Network

People needed

676

Starts

2014-12-01

Expected to finish

2017-09-01

Last updated by the study team

2017-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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
• 6 Sites — Different, Netherlands
• 3 Sites — Different, Spain
• 4 Sites — Different, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.