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

a study on Heart Conditions Atrial Fibrillation

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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

Details

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).

Keywords

Atrial Fibrillation Transcatheter Aortic Valve Implantation -- TAVI Anticoagulation ENVISAGE-TAVI-AF Edoxaban Edoxaban-based Regimen VKA-based Regimen

Eligibility

For people ages 18 years and up

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:
  • the safety or well-being of the participant or study staff
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  • the analysis of results

Locations

  • University of California - San Francisco accepting new patients
    San Francisco California 94143 United States
  • Santa Barbara Cottage Hospital accepting new patients
    Santa Barbara California 93105-4365 United States
  • UCLA Cardiovascular Center accepting new patients
    Los Angeles California 90095 United States
  • Cedar-Sinai Heart Institute accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo, Inc.
ID
NCT02943785
Phase
Phase 3
Study Type
Interventional
Last Updated
June 20, 2018