Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy
NCT ID: NCT02227550
Last Updated: 2017-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
676 participants
INTERVENTIONAL
2014-12-31
2017-09-30
Brief Summary
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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).
Detailed Description
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Patients can undergo catheter ablation within the trial after at least 30 days of continuous effective anticoagulation. Ablation can be performed earlier when or timely after exclusion of atrial thrombi have been excluded by a clinically indicated by transthoracic echocardioggram (TEE). After TEE continuous effective anticoagulation must be ensured until the end of the trial.
In the MRI-substudy will be explored wether novel oral anticoagulants (NOAC) have the potential to reduce clinically silent brain lesions after catheter ablation of AF.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Apixaban
Xa group: factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose)
Apixaban
factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose) dose reduction Apixaban 2,5 mg twice daily in patients who fulfill tow of the following criteria at the time of randomisation: chronic kidney disease (serum creatine \>= 1.5 mg/dl (133mM), \<= 60 kg body weight or age \>= 80 years.
Vitamin K antagonist
VKA group: any Vitamin K antagonist (VKA), INR 2-3 , min. 30 days prescribed as in clinical routine
Vitamin K antagonist
any locally used VKA, INR 2-3, min. 30 days according to aplicable medical guidelines and local clinical routin
Interventions
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Vitamin K antagonist
any locally used VKA, INR 2-3, min. 30 days according to aplicable medical guidelines and local clinical routin
Apixaban
factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose) dose reduction Apixaban 2,5 mg twice daily in patients who fulfill tow of the following criteria at the time of randomisation: chronic kidney disease (serum creatine \>= 1.5 mg/dl (133mM), \<= 60 kg body weight or age \>= 80 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
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.
E15. Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) \< 15 ml/min
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Pfizer
INDUSTRY
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
OTHER
Atrial Fibrillation Network
OTHER
Responsible Party
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Principal Investigators
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Paulus Kirchhof, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham Centre for Cardiovascular Scienes, UK and University Hospital Muenster, Germany
Locations
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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
Countries
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References
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Di Biase L, Callans D, Haeusler KG, Hindricks G, Al-Khalidi H, Mont L, Cosedis Nielsen J, Piccini JP, Schotten U, Kirchhof P. Rationale and design of AXAFA-AFNET 5: an investigator-initiated, randomized, open, blinded outcome assessment, multi-centre trial to comparing continuous apixaban to vitamin K antagonists in patients undergoing atrial fibrillation catheter ablation. Europace. 2017 Jan;19(1):132-138. doi: 10.1093/europace/euw368.
Haeusler KG, Eichner FA, Heuschmann PU, Fiebach JB, Engelhorn T, Callans D, De Potter T, Debruyne P, Scherr D, Hindricks G, Al-Khalidi HR, Mont L, Kim WY, Piccini JP, Schotten U, Themistoclakis S, Di Biase L, Kirchhof P. Detection of brain lesions after catheter ablation depends on imaging criteria: insights from AXAFA-AFNET 5 trial. Europace. 2023 Dec 6;25(12):euad323. doi: 10.1093/europace/euad323.
Haeusler KG, Eichner FA, Heuschmann PU, Fiebach JB, Engelhorn T, Blank B, Callans D, Elvan A, Grimaldi M, Hansen J, Hindricks G, Al-Khalidi HR, Mont L, Nielsen JC, Piccini JP, Schotten U, Themistoclakis S, Vijgen J, Di Biase L, Kirchhof P. MRI-Detected Brain Lesions and Cognitive Function in Patients With Atrial Fibrillation Undergoing Left Atrial Catheter Ablation in the Randomized AXAFA-AFNET 5 Trial. Circulation. 2022 Mar 22;145(12):906-915. doi: 10.1161/CIRCULATIONAHA.121.056320. Epub 2022 Feb 9.
Zink MD, Chua W, Zeemering S, di Biase L, Antoni BL, David C, Hindricks G, Haeusler KG, Al-Khalidi HR, Piccini JP, Mont L, Nielsen JC, Escobar LA, de Bono J, Van Gelder IC, de Potter T, Scherr D, Themistoclakis S, Todd D, Kirchhof P, Schotten U. Predictors of recurrence of atrial fibrillation within the first 3 months after ablation. Europace. 2020 Sep 1;22(9):1337-1344. doi: 10.1093/europace/euaa132.
Other Identifiers
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2014-002442-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AFNET 5 AXAFA
Identifier Type: -
Identifier Source: org_study_id