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



Status:Recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:March 21, 2017
End Date:November 2020
Contact:(for Japan sites only) Daiichi Sankyo Contact for Clinical Trial Information
Email:dsclinicaltrial@daiichisankyo.co.jp
Phone:+81-3-6225-1111 (M-F 9-5 JST)

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Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) - in Atrial Fibrillation

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.

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).

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
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