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Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation (ELIMINATE-AF)

This study is currently recruiting participants.
Verified November 2017 by Daiichi Sankyo, Inc. ( Daiichi Sankyo Europe, GmbH )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02942576
First Posted: October 24, 2016
Last Update Posted: November 17, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Europe, GmbH )
  Purpose
There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.

Condition Intervention Phase
Atrial Fibrillation Drug: Edoxaban Drug: VKA-Based Regimen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open-Label, Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban vs. VKA in Subjects Undergoing Catheter Ablation of Non-valvular Atrial Fibrillation (ELIMINATE-AF)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Europe, GmbH ):

Primary Outcome Measures:
  • Number of participants who experienced composite of all-cause death, stroke and major bleeding defined by the International Society on Thrombosis and Hemostasis (ISTH) [ Time Frame: Day 1 to Day 90 ]
    To compare descriptively the incidence of the composite of all-cause death, stroke (ischemic, hemorrhagic, or undetermined) and major bleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) in the edoxaban group against the vitamin K antagonist (VKA) group in subjects undergoing catheter ablation of atrial fibrillation (AF)

  • Number of participants who experienced major bleeding according to the ISTH definition [ Time Frame: Day 1 to Day 90 ]

Secondary Outcome Measures:
  • Number of participants who experienced composite of all-cause death, stroke and major bleeding according to ISTH and alternate definitions [ Time Frame: Day 1 to Day 90 ]
  • Number of participants who experienced the composite of stroke, systemic embolic events (SEE), and cardiovascular (CV) mortality [ Time Frame: Day 1 to Day 90 ]
  • Number of participants who experienced the composite of stroke, SEE, and all-cause mortality [ Time Frame: Day 1 to Day 90 ]
  • Number of participants who experienced the composite of stroke, and transient ischemic attack (TIA) [ Time Frame: Day 1 to Day 90 ]
  • Number of participants who experienced stroke [ Time Frame: Day 1 to Day 90 ]

Estimated Enrollment: 560
Actual Study Start Date: March 21, 2017
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Edoxaban-based regimen
Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period.
Drug: Edoxaban
Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects.
Other Name: Lixiana
Active Comparator: VKA-based regimen
VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)
Drug: VKA-Based Regimen
Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, UK, Taiwan and Korea.
Other Name: Warfarin
Drug: VKA-Based Regimen
Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.
Other Names:
  • Phenprogamma
  • Phenprocoumon
Drug: VKA-Based Regimen
Dosed at INR levels. Standard of Care treatment in France.
Other Names:
  • Previscan
  • Fluindione
Drug: VKA-Based Regimen
Dosed at INR levels. Standard of Care treatment in Spain.
Other Names:
  • Sintrom
  • Acenocoumarol

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or female at least 18 years of age with documented history of paroxysmal (lasting ≤7 days), persistent (lasting >7 days but ≤12 months) or long-standing [long-lasting] persistent (>12 months) non-valvular AF. Duration of AF can be confirmed by any electrical tracing or a recording in the subject's medical records (e.g., medical chart, hospital discharge summary).
  • Subject is eligible and is scheduled for either radio frequency (RF) or cryoballoon catheter ablation (both first and repeated procedure included).
  • Signed informed consent form (ICF).

Exclusion Criteria:

  • AF considered to be of a transient or reversible nature (such as in myocarditis, post-surgery, ionic disturbances, thyrotoxicosis, pneumonia, severe anemia etc.).
  • Subject post stroke, or with a systemic thromboembolic event within the past 6 months prior to randomization.
  • Subject has a thrombus in the left atrial appendage (LAA), left atrium (LA), left ventricle (LV), or aorta, or an intracardial mass.
  • Subject had a myocardial infarction (MI) within the 2 months prior to randomization or coronary artery bypass graft (CABG) surgery within 3 months prior to the randomization.
  • Subject has signs of bleeding, history of clinically-relevant bleeding according to ISTH, or conditions associated with high risk of bleeding
  • Subjects with any contraindication for anticoagulant agents.
  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): NCT02942576


  Show 81 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Europe, GmbH
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
  More Information

Publications:

Responsible Party: Daiichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT02942576     History of Changes
Other Study ID Numbers: DSE-EDO-01-16-EU
2016-003069-25 ( EudraCT Number )
First Submitted: October 21, 2016
First Posted: October 24, 2016
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States and the European Union from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Edoxaban
Phenprocoumon
Acenocoumarol
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants