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Atrial FibrillationPhase 4AXAFANCT02227550

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

A Phase 4 study testing Vitamin K antagonist and Apixaban in people with Atrial Fibrillation, run by Atrial Fibrillation Network at 13 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Vitamin K antagonist and Apixaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
676 participants
Where
13 sitesin 9 countries
Study dates
Dec 2014to Sep 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 10Show fewer
  • diabetes mellitus,
  • symptomatic heart failure (NYHA ≥ II).
  • I4. Age ≥ 18 years
  • I5. Provision of signed informed consent

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

13 sites in 9 countries.

13 sites in 9 countries

United States5 sites

  • Texas Cardiac Arrhythmia Research

    Austin, Texas

  • Vanderbilt University Medical Center

    Nashville, Tennessee

  • Montefiore Medical Center

    New York, New York

  • Sentara Cariovascular Research Insititute

    Norfolk, Virginia

  • Hospital of the University of Pennsyvlania

    Philadelphia, Pennsylvania

Other trials in United States

Austria1 site

  • 4 Sites

    Different

Other trials in Austria

Belgium1 site

  • 5 Sites

    Different

Other trials in Belgium

Denmark1 site

  • 5 Sites

    Different

Other trials in Denmark

Germany1 site

  • 13 Sites

    Different

Other trials in Germany

Italy1 site

  • 4 Sites

    Different

Other trials in Italy

Netherlands1 site

  • 6 Sites

    Different

Other trials in Netherlands

Spain1 site

  • 3 Sites

    Different

Other trials in Spain

United Kingdom1 site

  • 4 Sites

    Different

Other trials in United Kingdom

About this study

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

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).

Read the 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.

Being tested
Vitamin K antagonist, Apixaban
Keywords
Atrilal fibrillation, anticoagulation, prevention of peri-procedural complication, catheter ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin K antagonistDrug

    Also called warfarin, phenprocoumon, acecoumaril, fluindione

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

  • ApixabanDrug

    Also called BMS-562247

    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.

Study groups in NCT02227550
Study groupRoleWhat they receive
ApixabanExperimentalXa group: factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose)
Receives: Drug: Apixaban
Vitamin K antagonistActive comparatorVKA group: any Vitamin K antagonist (VKA), INR 2-3 , min. 30 days prescribed as in clinical routine
Receives: Drug: Vitamin K antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: appr. 4 months

Secondary outcomes (17)

  1. any bleeding event

    number

    Measured: appr. 4 months

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

    number

    Measured: appr. 4 months

  3. strokes, other systemic embolic events and all-cause death

    number

    Measured: appr. 4 month

  4. time from randomisation to ablation

    number of days

    Measured: appr. 4 months

  5. nights spent in hospital after ablation

    number

    Measured: appr. 4 months

  6. health-care related cost calculation

    Measured: appr. 4 months

  7. hospitalizations for cardiovascular reasons

    number

    Measured: appr. 4 months

  8. Treatment duration prior to ablation and total time on oral anticoagulation

    number of days

    Measured: appr. 4 months

  9. patients with clinically indicated TEE

    number of patients

    Measured: appr. 4 months

  10. ACT during ablation

    Active clotting measurements

    Measured: during ablation

  11. recurrent Atrial Fibrillation (AF)

    time to recurrent AF

    Measured: appr. 4 months

  12. rhythm status at the end of follow-up

    rythm status documented by 24 hour Holter ECG

    Measured: end of follow-up

  13. vascular access complications leading to prolongation of in-hospital stay or specific therapy

    number of events

    Measured: appr. 4 months

  14. Quality-of-life changes

    questionaire

    Measured: baseline to 3 month follow-up

  15. cognitive function change

    questionaire

    Measured: baseline to 3 month follow-up

  16. clinically "silent" MRI-detected brain lesions

    prevalence (MRI-substudy)

    Measured: within 48 hours after ablation procedures

  17. Impact of ablation-associated clinically overt strokes or MRI-detected bus clincally "silent" acute brain lesions on cognitive function after ablation

    MRI-substudy

    Measured: appr. 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionApr 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
676 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02227550
Sponsor's protocol ID
AFNET 5 AXAFA
Other IDs
2014-002442-45, 2014
Acronym
AXAFA
Status last verified
Oct 2017
First submitted
27 Jun 2014
Last updated
20 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28130378

  • 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.

    PubMed 37897713

  • 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.

    PubMed 35135308

  • 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.

    PubMed 32725107

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin K antagonist and Apixaban in people with Atrial Fibrillation, run by Atrial Fibrillation Network at 13 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Austria, Belgium, Denmark, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

death and serious cardiovascular events (time frame: appr. 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02227550, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.

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