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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02227550
First Posted: August 28, 2014
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bristol-Myers Squibb
Pfizer
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Atrial Fibrillation Network
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation Drug: Vitamin K antagonist Drug: Apixaban Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigator-driven, Prospective, Parallel-group, Randomised, Open, Blinded Outcome Assessment (PROBE), Multi-centre Trial to Determine the Optimal Anticoagulation Therapy for Patients Untergoing Catheter Ablation of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Atrial Fibrillation Network:

Primary Outcome Measures:
  • death and serious cardiovascular events [ Time Frame: appr. 4 months ]
    A composite of all-cause death, stroke (ischemic stroke, subarachnoid haemorrhage and haemorrhagic stroke), and major bleeding events, def.as BARC 2 or higher


Secondary Outcome Measures:
  • any bleeding event [ Time Frame: appr. 4 months ]
    number

  • major bleeding events acc. to the ISTH and TIMI definitions [ Time Frame: appr. 4 months ]
    number

  • strokes, other systemic embolic events and all-cause death [ Time Frame: appr. 4 month ]
    number

  • time from randomisation to ablation [ Time Frame: appr. 4 months ]
    number of days

  • nights spent in hospital after ablation [ Time Frame: appr. 4 months ]
    number

  • health-care related cost calculation [ Time Frame: appr. 4 months ]
  • hospitalizations for cardiovascular reasons [ Time Frame: appr. 4 months ]
    number

  • Treatment duration prior to ablation and total time on oral anticoagulation [ Time Frame: appr. 4 months ]
    number of days

  • patients with clinically indicated TEE [ Time Frame: appr. 4 months ]
    number of patients

  • ACT during ablation [ Time Frame: during ablation ]
    Active clotting measurements

  • recurrent Atrial Fibrillation (AF) [ Time Frame: appr. 4 months ]
    time to recurrent AF

  • rhythm status at the end of follow-up [ Time Frame: end of follow-up ]
    rythm status documented by 24 hour Holter ECG

  • vascular access complications leading to prolongation of in-hospital stay or specific therapy [ Time Frame: appr. 4 months ]
    number of events

  • Quality-of-life changes [ Time Frame: baseline to 3 month follow-up ]
    questionaire

  • cognitive function change [ Time Frame: baseline to 3 month follow-up ]
    questionaire

  • clinically "silent" MRI-detected brain lesions [ Time Frame: within 48 hours after ablation procedures ]
    prevalence (MRI-substudy)

  • Impact of ablation-associated clinically overt strokes or MRI-detected bus clincally "silent" acute brain lesions on cognitive function after ablation [ Time Frame: appr. 4 months ]
    MRI-substudy


Enrollment: 676
Study Start Date: December 2014
Study Completion Date: September 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apixaban
Xa group: factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose)
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.
Other Name: BMS-562247
Active Comparator: Vitamin K antagonist
VKA group: any Vitamin K antagonist (VKA), INR 2-3 , min. 30 days prescribed as in clinical routine
Drug: Vitamin K antagonist
any locally used VKA, INR 2-3, min. 30 days according to aplicable medical guidelines and local clinical routin
Other Names:
  • warfarin
  • phenprocoumon
  • acecoumaril
  • fluindione

Detailed Description:

AXAFA is an open-label trial designed to evaluate the safety and efficacy of two types of anticoagulant therapy, VKA therapy and therapy with the direct factor Xa inhibitor apixaban, in patients undergoing scheduled catheter ablation for AF. All patients will undergo the ablation procedure after pre-treatment with an anticoagulant (either apixaban in the "Xa group" or a vitamin K antagonist in the "VKA group").

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

I1. Non-valvular AF (ECG-documented) with a clinical indication for catheter ablation

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:

General exclusion criteria

E1. Any disease that limits life expectancy to less than 1 year

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).

Exclusion criteria related to a cardiac condition

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.

Exclusion criteria based on laboratory abnormalities

E15. Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) < 15 ml/min

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227550


Locations
United States, New York
Montefiore Medical Center
New York, New York, United States
United States, Pennsylvania
Hospital of the University of Pennsyvlania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States
United States, Texas
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
United States, Virginia
Sentara Cariovascular Research Insititute
Norfolk, Virginia, United States
Austria
4 Sites
Different, Austria
Belgium
5 Sites
Different, Belgium
Denmark
5 Sites
Different, Denmark
Germany
13 Sites
Different, Germany
Italy
4 Sites
Different, Italy
Netherlands
6 Sites
Different, Netherlands
Spain
3 Sites
Different, Spain
United Kingdom
4 Sites
Different, United Kingdom
Sponsors and Collaborators
Atrial Fibrillation Network
Bristol-Myers Squibb
Pfizer
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
Principal Investigator: Paulus Kirchhof, Professor University of Birmingham Centre for Cardiovascular Scienes, UK and University Hospital Muenster, Germany
  More Information

Publications:
Responsible Party: Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT02227550     History of Changes
Other Study ID Numbers: AFNET 5 AXAFA
2014-002442-45 ( EudraCT Number )
First Submitted: June 27, 2014
First Posted: August 28, 2014
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Atrial Fibrillation Network:
Atrilal fibrillation
anticoagulation
prevention of peri-procedural complication
catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamins
Vitamin K
Apixaban
Factor Xa Inhibitors
Phenprocoumon
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants