Status:
COMPLETED
Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy
Lead Sponsor:
Atrial Fibrillation Network
Collaborating Sponsors:
Bristol-Myers Squibb
Pfizer
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 o...
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 under...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
676 Patients enrolled
Trial Details
Trial ID
NCT02227550
Start Date
December 1 2014
End Date
September 1 2017
Last Update
October 20 2017
Active Locations (13)
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1
Montefiore Medical Center
New York, New York, United States
2
Hospital of the University of Pennsyvlania
Philadelphia, Pennsylvania, United States
3
Vanderbilt University Medical Center
Nashville, Tennessee, United States
4
Texas Cardiac Arrhythmia Research
Austin, Texas, United States