Trial · NCT02072434
Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
NCT02072434, Phase 3, Completed, Daiichi Sankyo; results first posted 2019-03-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF). Trials, record NCT02072434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02072434
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
- NCT number
- NCT02072434
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,199 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Atrial Fibrillation
- Interventions
- Edoxaban, Warfarin, Enoxaparin
- First posted
- 2014-02-26
- Last updated
- 2019-03-15
- Other registries' IDs
- eudract:2013-003148-21
- Results first posted
- 2019-03-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up | Randomization to end of follow-up (within 2 years) | |
| Primary | Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding | During treatment period (within 2 years) | |
| Secondary | Percentage of Participants With Composite Endpoints of Stroke, SEE, MI, CV Mortality, and Major Bleeding | From randomization to the end of follow-up (within 2 years) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up | Randomization to end of follow-up (within 2 years) | This outcome was assessed in the Intent-to-Treat (ITT) Analysis Set. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding | During treatment period (within 2 years) | This outcome was assessed in the Safety Analysis Set. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Composite Endpoints of Stroke, SEE, MI, CV Mortality, and Major Bleeding | From randomization to the end of follow-up (within 2 years) | This outcome was assessed in the ITT Analysis Set. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up | Edoxaban | 0.5 | Percentage of participants | ||
| Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up | Warfarin | 1 | Percentage of participants | ||
| Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding | Edoxaban | 1.5 | Percentage of participants | ||
| Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding | Warfarin | 1 | Percentage of participants | ||
| Percentage of Participants With Composite Endpoints of Stroke, SEE, MI, CV Mortality, and Major Bleeding | Edoxaban | 0.7 | Percentage of participants | ||
| Percentage of Participants With Composite Endpoints of Stroke, SEE, MI, CV Mortality, and Major Bleeding | Warfarin | 1.4 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Edoxaban | 1,095 | |
| Overall Study | STARTED | Warfarin | 1,104 | |
| Overall Study | Intent to Treat Analysis Set | Edoxaban | 1,095 | |
| Overall Study | Intent to Treat Analysis Set | Warfarin | 1,104 | |
| Overall Study | Received Study Drug | Edoxaban | 1,067 | |
| Overall Study | Received Study Drug | Warfarin | 1,082 | |
| Overall Study | Safety Analysis Set | Edoxaban | 1,067 | |
| Overall Study | Safety Analysis Set | Warfarin | 1,082 | |
| Overall Study | COMPLETED | Edoxaban | 1,041 | |
| Overall Study | COMPLETED | Warfarin | 1,014 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events212
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial fibrillation | Cardiac disorders | Edoxaban | 53 | 1,067 | 53 |
| other | Atrial fibrillation | Cardiac disorders | Warfarin | 53 | 1,082 | 53 |
| serious | Hypertensive crisis | Vascular disorders | Edoxaban | 1 | 1,067 | 1 |
| serious | Hypertensive crisis | Vascular disorders | Warfarin | 1 | 1,082 | 1 |
| serious | Aortic aneurysm rupture | Vascular disorders | Edoxaban | 0 | 1,067 | 0 |
| serious | Aortic aneurysm rupture | Vascular disorders | Warfarin | 1 | 1,082 | 1 |
| serious | Deep vein thrombosis | Vascular disorders | Edoxaban | 1 | 1,067 | 1 |
| serious | Deep vein thrombosis | Vascular disorders | Warfarin | 0 | 1,082 | 0 |
| serious | Haemodynamic instability | Vascular disorders | Edoxaban | 1 | 1,067 | 1 |
| serious | Haemodynamic instability | Vascular disorders | Warfarin | 0 | 1,082 | 0 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Edoxaban | 1 | 1,067 |
| Total, all-cause mortality | Warfarin | 5 | 1,082 |
| Total, other adverse events | Edoxaban | 53 | 1,067 |
| Total, other adverse events | Warfarin | 53 | 1,082 |
| Total, serious adverse events | Edoxaban | 85 | 1,067 |
| Total, serious adverse events | Warfarin | 83 | 1,082 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Edoxaban vs Warfarin: deaths from any cause | Trial comparisons |
| Edoxaban vs Warfarin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02072434
GET https://conductscience.org/api/trials/v1/NCT02072434/events?page=2