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Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)

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ClinicalTrials.gov Identifier: NCT02943785
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:

When the upper chambers of a person's heart receive irregular electrical signals it causes abnormal rhythm in the heart beat. This is called atrial fibrillation.

Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients also get new heart valves using a catheter.

Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is considered the standard care. This study will see how edoxaban compares to VKA in patients who got a new heart valve by using a catheter.

The study will compare the two drugs for up to three years after heart valve replacement, looking at the drug's overall side effects (called adverse events) and major bleeding.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Edoxaban-based Regimen Drug: VKA-based Regimen Phase 3

Detailed Description:

Use of Edoxaban in patients with atrial fibrillation (AF) and indication to chronic oral anticoagulation (OAC) after transcatheter aortic valve implantation (TAVI)

Objective:

  • To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis [ISTH] definition).
  • To assess the effect of Edoxaban versus VKA on major bleeding (ISTH definition).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) - in Atrial Fibrillation
Actual Study Start Date : March 21, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Edoxaban-based Regimen
Edoxaban-based regimen 60 mg and 30 mg film coated tablet for once-daily oral use, and 15 mg film coated tablet for transitioning at end of treatment. Dosing must follow the locally approved label.
Drug: Edoxaban-based Regimen
15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed)
Other Names:
  • Savaysa
  • Lixiana
Active Comparator: VKA-based Regimen
VKA-based regimen oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator will monitor the patient and adjust the VKA dose to maintain the dose within target.
Drug: VKA-based Regimen
Dosed at International Normalized Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in the country location (with anti-platelet therapy pre-declared at randomization if prescribed).



Primary Outcome Measures :
  1. Number of participants experiencing the described adverse event composite within 36 months (ISTH definition) [ Time Frame: within 36 months ]
    Adverse event composite included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding per definition of the International Society on Thrombosis and Haemostasis (ISTH].

  2. Number of participants experiencing major bleeding (ISTH definition) [ Time Frame: within 36 months ]

Secondary Outcome Measures :
  1. Number of participants experiencing the described adverse event composite within 36 months (non-ISTH definition) [ Time Frame: within 36 months ]
    This adverse event composite included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding per definitions other than those of the International Society on Thrombosis and Haemostasis (ISTH]

  2. Percentage of participants experiencing major bleeding per other than ISTH definition [ Time Frame: within 36 months ]
    Other than ISTH definitions include Thrombolysis in Myocardial Infarction (TIMI) and Bleeding Academic Research Consortium (BARC)

  3. Percentage of participants experiencing stroke (ischemic, hemorrhagic, or undetermined) [ Time Frame: Baseline to 36 months ]
    Description: Categories will include Any Stroke, Fatal Stroke, Non-fatal Stroke

  4. Percentage of participants experiencing systemic embolic events (SEE) [ Time Frame: Baseline to 36 months ]


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

Criteria : Inclusion Criteria:

  • Meets protocol-specified criteria for qualification and contraception
  • Is willing and able to comply with any restrictions related food, drink and medications
  • Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

  • Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
  • Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

    1. the safety or well-being of the participant or study staff
    2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
    3. the analysis of results

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): NCT02943785


  Show 128 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Chiltern International Inc.
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02943785     History of Changes
Other Study ID Numbers: DU176B-C-U4001
2016-003930-26 ( EudraCT Number )
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

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

Keywords provided by Daiichi Sankyo, Inc.:
Transcatheter Aortic Valve Implantation -- TAVI
Anticoagulation
Atrial Fibrillation
ENVISAGE-TAVI-AF

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