NCT02227550

Brief 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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
676

participants targeted

Target at P75+ for phase_4 atrial-fibrillation

Timeline
Completed

Started Dec 2014

Geographic Reach
9 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

June 27, 2014

Last Update Submit

October 19, 2017

Conditions

Atrial Fibrillation

Keywords

Atrilal fibrillationanticoagulationprevention of peri-procedural complicationcatheter ablation

Outcome Measures

Primary Outcomes (1)

  • death and serious cardiovascular events

    A composite of all-cause death, stroke (ischemic stroke, subarachnoid haemorrhage and haemorrhagic stroke), and major bleeding events, def.as BARC 2 or higher

    appr. 4 months

Secondary Outcomes (17)

  • any bleeding event

    appr. 4 months

  • major bleeding events acc. to the ISTH and TIMI definitions

    appr. 4 months

  • strokes, other systemic embolic events and all-cause death

    appr. 4 month

  • time from randomisation to ablation

    appr. 4 months

  • nights spent in hospital after ablation

    appr. 4 months

  • +12 more secondary outcomes

Study Arms (2)

Apixaban

EXPERIMENTAL

Xa group: factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose)

Drug: Apixaban

Vitamin K antagonist

ACTIVE COMPARATOR

VKA group: any Vitamin K antagonist (VKA), INR 2-3 , min. 30 days prescribed as in clinical routine

Drug: Vitamin K antagonist

Interventions

Vitamin K antagonistDRUG

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

Also known as: warfarin, phenprocoumon, acecoumaril, fluindione
Vitamin K antagonist
ApixabanDRUG

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.

Also known as: BMS-562247
Apixaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Montefiore Medical Center

New York, New York, United States

Location

Hospital of the University of Pennsyvlania

Philadelphia, Pennsylvania, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Location

Texas Cardiac Arrhythmia Research

Austin, Texas, United States

Location

Sentara Cariovascular Research Insititute

Norfolk, Virginia, United States

Location

4 Sites

Different, Austria

Location

5 Sites

Different, Belgium

Location

5 Sites

Different, Denmark

Location

13 Sites

Different, Germany

Location

4 Sites

Different, Italy

Location

6 Sites

Different, Netherlands

Location

3 Sites

Different, Spain

Location

4 Sites

Different, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 28130378BACKGROUND

  • 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.

    PMID: 37897713DERIVED

  • 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.

    PMID: 35135308DERIVED

  • 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.

    PMID: 32725107DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

acarboxyprothrombinWarfarinPhenprocoumonfluindioneapixaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Paulus Kirchhof, Professor

    University of Birmingham Centre for Cardiovascular Scienes, UK and University Hospital Muenster, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2014

First Posted

August 28, 2014

Study Start

December 1, 2014

Primary Completion

April 1, 2017

Study Completion

September 1, 2017

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

BE(1)US(5)DE(1)ES(1)GB(1)NL(1)DK(1)IT(1)AU(1)