During atrial fibrillation catheter ablation procedure treatment with anticoagulant drugs is necessary in order to prevent blood clotting and thereby decrease the risk of procedure related strokes. In this study two different types of anticoagulant drugs are being compared during and after the atrial fibrillation catheter ablation procedure: the novel direct factor Xa inhibitor apixaban and any of the standard vitamin K antagonists.

Phase 1

• Conditions: Atrial fibrillation catheter ablation; MedDRA version: 19.1Level: LLTClassification code 10066582Term: Recurrent atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 19.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 19.1Level: LLTClassification code 10003661Term: Atrial fibrillation paroxysmalSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 19.1Level: LLTClassification code 10071667Term: Persistent atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2014-002442-45-DK
• Lead Sponsor: Kompetenznetz Vorhofflimmern e.V. [Atrial Fibrillation NETwork (AFNET)]

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-10
• Last Update Posted: 6 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 650

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

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
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
Exclusion criteria based on laboratory abnormalities
E14. Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) < 15 ml/min

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified