Trials / Completed
CompletedNCT02942576
Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation
A Prospective, Randomized, Open-Label, Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban vs. VKA in Subjects Undergoing Catheter Ablation of Non-valvular Atrial Fibrillation (ELIMINATE-AF)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 632 (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 therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Edoxaban | Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects. |
| DRUG | VKA-Based Regimen | Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, United Kingdom (UK), Taiwan and Korea. |
| DRUG | VKA-Based Regimen | Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands. |
| DRUG | VKA-Based Regimen | Dosed at INR levels. Standard of Care treatment in France. |
| DRUG | VKA-Based Regimen | Dosed at INR levels. Standard of Care treatment in Spain. |
Timeline
- Start date
- 2017-03-21
- Primary completion
- 2018-09-24
- Completion
- 2018-09-24
- First posted
- 2016-10-24
- Last updated
- 2019-09-23
- Results posted
- 2019-09-23
Locations
75 sites across 11 countries: Belgium, Canada, Czechia, Germany, Hungary, Italy, Poland, South Korea, Spain, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT02942576. Inclusion in this directory is not an endorsement.