Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02943785 · ClinicalTrials.gov registry record · Phase 3
Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
A Phase 3 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,426
- Enrollment target
NCT02943785: Completed Phase 3 study, sponsored by Daiichi Sankyo.
NCT02943785 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 1,426 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02943785, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,426 participants
- Enrollment target
Study Summary
When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation. Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart attack. Some patients with atrial fibrillation have other heart disease, such as heart valves that may need to be replaced using catheters. Often doctors give patients drugs that reduce those blood clots. These are either vitamin K antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear which of the drugs is better for reducing stroke without increasing severe bleedings.
Primary Outcome
The composite endpoint net adverse clinical events (NACE) included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding per definition of the International Society on Thrombosis and Haemostasis (ISTH\].
Interventions
- DRUG Edoxaban-based Regimen
- DRUG VKA-based Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,426 participants |
| Start Date | 2017-03-21 |
| Est. Completion | 2021-02-28 |
| Phase | Phase 3 |
What the finished NCT02943785 record still lists
NCT02943785 is an interventional study that assigns participants to a tested intervention. Its 1,426 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% higher).
The record links to 0 conditions, and to 2 interventions - of which Edoxaban-based Regimen is the first listed.
NCT02943785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02943785 about?
NCT02943785 is a clinical study titled "Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)". When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation. Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart ...
What is the current status of trial NCT02943785?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,426 participants. The study started on 2017-03-21. Estimated completion is 2021-02-28.
What interventions are being tested in trial NCT02943785?
The interventions under investigation include: Edoxaban-based Regimen (DRUG), VKA-based Regimen (DRUG).
Who is sponsoring clinical trial NCT02943785?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02943785's enrollment target sits among peer trials
1,426 169th of 2000 higher than 1,832 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04754022 · 1,440 participants · NA
Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
- NCT04989790 · 1,440 participants · NA
Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children
- NCT06122246 · 1,440 participants · NA
PRESSURE CHECK: Find Your Path to Better Health
- NCT06324318 · 1,440 participants · Phase 2
Parenting in 2 Worlds Multisite Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI