Anticoagulation using the direct factor Xa inhibitor apixaban during Atrial Fibrillation catheter Ablation: Comparison to vitamin K antagonist therapy

Phase 4

Completed

• Conditions: on-valvular atrial fibrillation with a clinical indication for catheter ablation/bleeding + stroke risk/cardiology; Circulatory System; Atrial fibrillation

• Registration Number: ISRCTN87711003
• Lead Sponsor: Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]

Brief Summary

2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/28130378 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29579168 [added 13/05/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-20
• Study Completion: 2017-09-12
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 674

Inclusion Criteria

1. Non-valvular AF (ECG-documented) with a clinical indication for catheter ablation
2. Clinical indication to undergo catheter ablation on continuous anticoagulant therapy
3. Presence of at least one of the CHADS2 stroke risk factors
3a. Stroke or TIA
3b. Age =75 years
3c. Hypertension, defined as chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure >145/90 mm Hg
3d. Diabetes mellitus
3e. Symptomatic heart failure (NYHA =II)
4. Age =18 years
5. Provision of signed informed consent

Exclusion Criteria

General exclusion criteria
1. Any disease that limits life expectancy to less than 1 year
2. Participation in another clinical trial, either within the past two months or still ongoing
3. Previous participation in AXAFA
4. 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.
5. Breastfeeding women
6. Drug abuse or clinically manifest alcohol abuse
Added 18/10/2017:
7. Any stroke within 14 days before randomisation
8. 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
9. 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.
10. Any previous ablation or surgical therapy for AF
11. Cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation
12. Clinical need for ?triple therapy? (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation)
13. Other contraindications for use of VKA or apixaban

Exclusion criteria based on laboratory abnormalities
14. Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) <15 ml/min
Added 18/10/2017: 15. Documented atrial thrombi less than 3 months prior to randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> A composite of<br> 1. All-cause death<br> 2. Stroke (ischemic stroke, subarachnoid hemorrhage and hemorrhagic stroke)<br> 3. Major bleeding events, defined as BARC 2 or higher<br>