CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,506 enrolled
Drug / intervention
Edoxaban +4 moredrug
Likely dose
Edoxaban 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02866175
NCT02866175Phase 3Completed
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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.

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company·interventional·Posted Aug 15, 2016·Updated May 6, 2020

In Brief

A Phase 3 clinical trial evaluating Edoxaban, Clopidogrel, and 3 other interventions for Atrial Fibrillation. Completed, enrolled 1,506 participants across 200 sites in 18 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesAustria, Belgium, France, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Serbia, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 15, 2016
Enrollment StartFeb 24, 2017
Primary CompletionJun 6, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.9 years ago

Interventions

Edoxabandrug

Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects

Clopidogreldrug

Clopidogrel 75 mg once-daily

Prasugreldrug

prasugrel 5mg or 10 mg once-daily

Ticagrelordrug

ticagrelor 90 mg twice-daily

Vitamin K antagonistdrug

VKA once-daily dosing for target international normalized ratio between 2.0 and 3.0, inclusive