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

NCT02227550

Last updated date
Study Location
Montefiore Medical Center
New York, New York, , United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Atrial FibrillationIntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4
NCT01740037
  1. Groningen,
  2. Groningen,
  3. Haarlem,
  4. Leeuwarden,
  5. Maastricht,
  6. Nijmegen,
  7. Zaandam,
  8. Zwolle,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Atrial FibrillationEvaluation of Safety and Effectiveness on Oral Anticoagulants
NCT03765242
  1. Minato-ku, Tokyo
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Atrial FibrillationAmiodarone to Prevent Post-Operative Arrhythmias
NCT00251706
  1. Calgary, Alberta
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy
Official Title  ICMJE 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
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).

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Apixaban
    Xa group: factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose)
    Intervention: Drug: Apixaban
  • Active Comparator: Vitamin K antagonist
    VKA group: any Vitamin K antagonist (VKA), INR 2-3 , min. 30 days prescribed as in clinical routine
    Intervention: Drug: Vitamin K antagonist
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2017)
676
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2014)
650
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02227550
Other Study ID Numbers  ICMJE AFNET 5 AXAFA
2014-002442-45 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Atrial Fibrillation Network
Study Sponsor  ICMJE Atrial Fibrillation Network
Collaborators  ICMJE
  • Bristol-Myers Squibb
  • Pfizer
  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators  ICMJE
Principal Investigator:Paulus Kirchhof, ProfessorUniversity of Birmingham Centre for Cardiovascular Scienes, UK and University Hospital Muenster, Germany
PRS Account Atrial Fibrillation Network
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP