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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44975

Enrollment

Registered

2017-03-21

Start date

2015-09-24

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation cardiac rhythm disturbance

Interventions

Investigational medicinal product: apixaban Comparator: locally used, marketed VKA Apixaban will be given 5 mg twice daily and compared to oral anticoagulation using the locally used VKA (aiming for

Artrial Fibrilation

Catheter ablation

Continuous anticoagulation

Peri-procedural complications

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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 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)

Design outcomes

Primary

Measure	Time frame
A composite of - all-cause death, - stroke (ischemic stroke, subarachnoid haemorrhage and haemorrhagic stroke), and - major bleeding events, defined as BARC 2 or higher	—

Secondary

Measure	Time frame
- Any bleeding event - Major bleeding events according to the ISTH and TIMI definitions - Number of strokes, other systemic embolic events, and all-cause deaths - Time from randomisation to ablation - Nights spent in hospital after ablation - Health-care related cost calculation - Number of hospitalisations for cardiovascular reasons - Treatment duration prior to ablation and total time on oral anticoagulation - Number of patients with clinically indicated TEE - ACT during ablation - Time to recurrent AF - Rhythm status at the end of follow-up - Vascular access complications leading to prolongation of in-hospital stay or specific therapy - Quality-of-life changes at month 3 compared to baseline - Cognitive function change at month 3 compared to baseline - Prevalence of clinically silent MRI-detected brain lesions within 48 hours after the ablation procedure (MRI sub-study), - Impact of ablation-associated clinically overt strokes or MRI-detected but clinically silent acute brain lesions on cognitive function after ablation (MRI sub-study)	—

Measure

Time frame

- Any bleeding event - Major bleeding events according to the ISTH and TIMI definitions - Number of strokes, other systemic embolic events, and all-cause deaths - Time from randomisation to ablation - Nights spent in hospital after ablation - Health-care related cost calculation - Number of hospitalisations for cardiovascular reasons - Treatment duration prior to ablation and total time on oral anticoagulation - Number of patients with clinically indicated TEE - ACT during ablation - Time to recurrent AF - Rhythm status at the end of follow-up - Vascular access complications leading to prolongation of in-hospital stay or specific therapy - Quality-of-life changes at month 3 compared to baseline - Cognitive function change at month 3 compared to baseline - Prevalence of clinically *silent* MRI-detected brain lesions within 48 hours after the ablation procedure (MRI sub-study), - Impact of ablation-associated clinically overt strokes or MRI-detected but clinically *silent* acute brain lesions on cognitive function after ablation (MRI sub-study)

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Countries

Austria, Belgium, Denmark, Germany, Italy, Netherlands, Spain, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)