drugset / Trial / NCT02227550
Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy
Phase 4
Completed
676 enrolled
Atrial Fibrillation Network
Bristol-Myers Squibb · collabDeutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) · collabPfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Study objective is to demonstrate that anticoagulation with the direct factor Xa inhibitor apixaban is not less safe than Vitamin-K-antagonists (VKA) therapy in patients undergoing catheter ablation of non-valvular AF in the prevention of peri-procedural complications. 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).
Timeline
- Start
- 2014-12
- Primary completion
- 2017-04
- Completion
- 2017-09
Publications
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 2.5 mg | Oral |
| Subject | Apixaban | Small molecule | 5 mg | Oral |
| Comparator | Fluindione | Small molecule | — | — |
| Comparator | Phenprocoumon | Small molecule | — | — |
| Comparator | Warfarin | Small molecule | — | — |