AXAFA – AFNET 5
Research type
Research Study
Full title
AXAFA - AFNET 5 Anticoagulation using the direct factor Xa inhibitor apixaban during Atrial Fibrillation catheter Ablation: Comparison to vitamin K antagonist therapy.
IRAS ID
169447
Contact name
Günter Breithardt
Contact email
Sponsor organisation
The Kompetenznetz Vorhofflimmern e.V. [German Atrial Fibrillation Competence Network association (AF
Eudract number
2014-002442-45
ISRCTN Number
ISRCTN87711003
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 4 days
Research summary
The AXAFA trial is a multi-centre trial comparing treatment with newer type of medication, called Factor Xa inhibitor, with brand name of Apixaban to treatment with Vitamin K Antagonists, an older type of medication, in patients undergoing catheter ablation for atrial fibrillation (AF). The patients will be randomised (a computer will assign which medication they will receive) to either Apixaban or Vitamin K antagonist (VKA) and their health care providers will not be blinded which medication their patients are assigned to (open label). In total 630 patients will be randomised to either medication, both of which are licensed and currently used in the UK in this patient population. Ischaemic and bleeding events information will be collected for approximately 3 months following the catheter ablation appointment.
The test medication in this trial is a licensed, already used in the UK newer type of anticoagulant called Apixaban, and the comparators are the older, Vitamin K Antagonist types of medication. The rates and types of complications for the older type of medication are well known, and the trial seeks to demonstrate that such adverse events will be no higher for the newer type of medication.
The aim of the trial is to demonstrate that treatment with the newer, and recommended by NICE (National Institute for Clinical Excellence) factor Xa inhibitor Apixaban is as safe as treatment with the older, commonly used Vitamin K antagonists in patients undergoing catheter ablation for atrial fibrillation (AF). The trial also aims to compare the rates and nature of complications during and following the ablation whilst using these medicines.
Moreover some participants will be offered an MRI (Magnetic Resonance Imaging) scan, a non-invasive brain scan to see if the newer medication (Apixaban) is better in preventing strokes and clots compared to the Vitamin K Antagonists routinely used in the UK clinical practice.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0077
Date of REC Opinion
26 May 2015
REC opinion
Further Information Favourable Opinion