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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 not yet open for participant recruitment.
See Contacts and Locations
Verified October 2016 by Daiichi Sankyo Inc. ( Daiichi Sankyo Europe, GmbH )
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Europe, GmbH )
ClinicalTrials.gov Identifier:
NCT02942576
First received: October 21, 2016
Last updated: NA
Last verified: October 2016
History: No changes posted
  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: 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
Study Start Date: March 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02942576

Contacts
Contact: Iris Wittmann +49 2208 5019 345 Iris.Wittmann@chiltern.com
Contact: Dmytro Kobyshcha 38 067 466 9434 Dmytro.Kobyshcha@chiltern.com

Sponsors and Collaborators
Daiichi Sankyo Europe, GmbH
  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
2016-002683-14 ( EudraCT Number )
Study First Received: October 21, 2016
Last Updated: October 21, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

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

ClinicalTrials.gov processed this record on June 23, 2017