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NCT02561897 · ClinicalTrials.gov registry record · Phase 4
EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation
A Phase 4 study, sponsored by Electrophysiology Research Foundation.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT02561897: Clinical Trial Phase 4 study, sponsored by Electrophysiology Research Foundation.
NCT02561897 is a Phase 4 study that was terminated before completion, run by Electrophysiology Research Foundation. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02561897, a Phase 4 study, was terminated before completion, sponsored by Electrophysiology Research Foundation.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.
Primary Outcome
Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure
Interventions
- DRUG Warfarin
- DRUG Edoxaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-12 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
Why NCT02561897 stopped before completion
NCT02561897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT02561897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02561897 about?
NCT02561897 is a clinical study titled "EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation". This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primar...
What is the current status of trial NCT02561897?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2015-12. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02561897?
The interventions under investigation include: Warfarin (DRUG), Edoxaban (DRUG).
Who is sponsoring clinical trial NCT02561897?
This trial is sponsored by Electrophysiology Research Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02561897's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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