AXAFA – AFNET 5 Trial

Title

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

This study is partially funded by the DZHK

Summary

AXAFA – AFNET 5 is an investigator-driven, prospective, parallel-group, randomised, open, blinded outcome assessment (PROBE), multi-centre trial to determine the optimal anticoagulation therapy for patients undergoing catheter ablation of atrial fibrillation.
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Current Status

Patient enrolment endend on 10.04.2017
674 patientes enrolled
49 sites were open for recruitment
Status as of 29.06.2017

Planned Number of Patients

630

Participating Countries

Europe, USA

International Chief Investigator

Prof. Paulus Kirchhof, Birmingham, UK / Münster, Germany

Overall Responsibility

Atrial Fibrillation NETwork (AFNET), Münster, Germany

Partner

German Centre for Cardiovascular Research (DZHK)

Funding

Bristol-Myers Squibb

Pfizer

Info-Flyer für Studienärzte

Publications

Haeusler KG, Eichner F. A.; Heuschmann P. U.; Fiebach J. B. Engelhorn T, Blank B, Callans D, Elvan A, Grimaldi M, Hansen J, Hindricks G, Al-Khalidi HR, Mont L, Cosedis Nielsen J, 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;145:906–915. doi: 10.1161/CIRCULATIONAHA.121.056320.

Zink MD, Chua W, Zeemering S, di Biase L, Bayes de Luna A, Callans D, Hindricks G, Haeusler KG, Al-Khalidi HR, Piccini JP, Mont L, Cosedis Nielsen J, Alberto Escobar L, 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. EP Europace. euaa132. doi: 10.1093/europace/euaa132.

Kloosterman M, Chua W, Fabritz L, Al-Khalidi HR, Schotten U, Nielsen JC, Piccini JP, Di Biase L, Häusler KG, Todd D, Mont L, Van Gelder IC, Kirchhof P. for the AXAFA-AFNET 5 investigators. Sex differences in catheter ablation of atrial fibrillation: results from AXAFA-AFNET 5. EP Europace. 2020 July; Volume 22; Issue 7; Pages 1026–1035. doi: 10.1093/europace/euaa015.

Kirchhof P, Haeusler KG, Blank B, De Bono J, Callans D, Elvan A, Fetsch T, Van Gelder IC, Gentlesk P, Grimaldi M, Hansen J, Hindricks G, Al-Khalidi HR, Massaro T, Mont L, Nielsen JC, Nölker G, Piccini JP, De Potter T, Scherr D, Schotten U, Themistoclakis S, Todd D, Vijgen J, Di Biase L. Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation. Eur Heart J. 2018 Aug 21; 00:1-14. doi: 10.1093/eurheartj/ehy176. Epub 2018 Mar 20.

Di Biase L, Callans D, Georg Haeusler K, 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. Epub 2016 Oct 14.

Registration

EudraCT number: 2014-002442-45
ClinicalTrials.gov: NCT02227550
ISRCTN: ISRCTN87711003

Contact

Kompetenznetz Vorhofflimmern e.V.
Mendelstraße 11
48149 Münster, Germany
Phone: +49 251 980 1330
Fax: +49 251 980 1349
Email: info[at]kompetenznetz-vorhofflimmern.de
http://www.kompetenznetz-vorhofflimmern.de