NCT02866175

Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

Evaluation of the Safety and Efficacy of an Edoxaban-based Compared to a Vitamin K Antagonist-based Antithrombotic Regimen in Subjects With Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) With Stent Placement.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,506 (actual)
• Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting. This study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a vitamin K antagonist (VKA)-based antithrombotic regimen in subjects with AF following PCI with stent placement. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Edoxaban	Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects
DRUG	Clopidogrel	Clopidogrel 75 mg once-daily
DRUG	Prasugrel	prasugrel 5mg or 10 mg once-daily
DRUG	Ticagrelor	ticagrelor 90 mg twice-daily
DRUG	Vitamin K antagonist	VKA once-daily dosing for target international normalized ratio between 2.0 and 3.0, inclusive

Timeline

• Start date: 2017-02-24
• Primary completion: 2019-06-06
• Completion: 2019-06-06
• First posted: 2016-08-15
• Last updated: 2020-05-06
• Results posted: 2020-05-06

Locations

200 sites across 18 countries: Austria, Belgium, France, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Serbia, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom