Overview

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

Status:
Completed

Trial end date:
2021-02-28

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Daiichi Sankyo Inc.
Daiichi Sankyo, Inc.

Collaborator:

Chiltern International Inc.

Treatments:

Acenocoumarol
Edoxaban
Phenprocoumon
Warfarin