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Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy

NCT02227550 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 676

Last updated 2017-10-20

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Vitamin K antagonist

any locally used VKA, INR 2-3, min. 30 days according to aplicable medical guidelines and local clinical routin

DRUG

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.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • Atrial Fibrillation Network

    lead OTHER

Principal Investigators

  • Paulus Kirchhof, Professor · University of Birmingham Centre for Cardiovascular Scienes, UK and University Hospital Muenster, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-04-30
Completion
2017-09-30

Countries

  • United States
  • Austria
  • Belgium
  • Denmark
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02227550 on ClinicalTrials.gov