Trial · NCT02866175
Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
NCT02866175, Phase 3, Completed, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company; results first posted 2020-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention. Trials, record NCT02866175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02866175
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
- NCT number
- NCT02866175
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,506 participants, actual
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Conditions
- Atrial Fibrillation
- Interventions
- Edoxaban, Clopidogrel, Prasugrel, Ticagrelor, Vitamin K antagonist
- First posted
- 2016-08-15
- Last updated
- 2020-05-06
- Other registries' IDs
- eudract:2016-002683-14
- Results first posted
- 2020-05-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 12 months postdose | Participants' first major or clinically relevant non-major bleeding (MCRB) events were reported. International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: MCRB, major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding. |
| Secondary | Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen | Day 1 to 12 months postdose | All major, clinically relevant non-major and minor bleeding are reported for the secondary outcome. Participants may have experiences more than 1 bleeding event, all occurrences are reported. Participants with International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: major or clinically relevant non-major bleeding (MCRB), major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding. |
| Secondary | Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 12 months postdose | Thrombolysis in Myocardial Infarction (TIMI) defined bleeding events included: Major bleeding (including fatal bleeding and non-fatal bleeding \[fulfilling the TIMI major bleeding definition\], major or minor bleeding, minor bleeding, minimal bleeding, and any bleeding (defined as composite of major, minor, and minimal bleeding) |
| Secondary | Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 12 months postdose | Bleeding Academic Research Consortium (BARC) bleeding events included: Bleeding (defined by BARC type 3 or 5), bleeding (defined by BARC type 2, 3, or 5), and any bleeding (defined as the composite of BARC type 1, 2, 3, or 5), where increases in BARC type indicate worse outcome. Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consultation; Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation; Type 3: Overt bleeding plus hemoglobin drop of 3 to ≤5 g/dL (3a), ≥5 g/dl (3b), and intracranial hemorrhage (3c) Type 5: Fatal bleeding |
| Secondary | Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 12 months postdose | The main efficacy endpoints were defined as the composite of cardiovascular death (ARC), stroke (protocol defined), systemic embolic event (SEE), myocardial infarction (MI), or definite stent thrombosis. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 30 days after the last dose | Treatment-emergent adverse events (TEAEs) in \>1.0% of participants were defined as events which started on or after first dose of the assigned study drug (edoxaban and VKA) or started prior to but then worsened after the first dose of the assigned study drug. |
| Secondary | Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 30 days after the last dose | Study drug-related treatment-emergent adverse events (TEAEs) (experienced by 2 or more participants) were defined as events which started on or after first dose of the assigned study drug (edoxaban and VKA) or started prior to but then worsened after the first dose of the assigned study drug and were found to be related to treatment by the Investigator. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 12 months postdose | First major or clinically relevant non-major bleeding was assessed in the Intent-to-Treat Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen | Day 1 to 12 months postdose | All major, clinically relevant non-major, and minor bleeding events were assessed in the Intent-to-Treat Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 12 months postdose | Major, minor, and minimal bleeding was assessed in the Intent-to-Treat Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 12 months postdose | BARC type 1, 2, 3, and 5 bleeding was assessed in the Intent-to-Treat Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 12 months postdose | Efficacy endpoints were assessed in the Intent-to-Treat Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 30 days after the last dose | Safety events were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Day 1 to 30 days after the last dose | Safety events were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group246
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Edoxaban Regimen | Composite MCRB | 128 | Participants | |
Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Vitamin K Antagonist Regimen | Composite MCRB | 152 | Participants | |
Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Edoxaban Regimen | Major bleeding | 39 | Participants | |
Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Vitamin K Antagonist Regimen | Major bleeding | 44 | Participants | |
Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Edoxaban Regimen | Clinically relevant non-major bleeding | 89 | Participants | |
Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen | Vitamin K Antagonist Regimen | Clinically relevant non-major bleeding | 108 | Participants | |
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen | Edoxaban Regimen | Major bleeding | 45 | Participants | |
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen | Vitamin K Antagonist Regimen | Major bleeding | 48 | Participants | |
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen | Edoxaban Regimen | Clinically relevant non-major bleeding | 97 | Participants | |
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen | Vitamin K Antagonist Regimen | Clinically relevant non-major bleeding | 114 | Participants |
1 to 10 of 246Source ClinicalTrials.gov
See all 246 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Edoxaban Regimen | 751 | |
| Overall Study | STARTED | Vitamin K Antagonist Regimen | 755 | |
| Overall Study | COMPLETED | Edoxaban Regimen | 616 | |
| Overall Study | COMPLETED | Vitamin K Antagonist Regimen | 580 | |
| Overall Study | NOT COMPLETED | Edoxaban Regimen | 135 | |
| Overall Study | NOT COMPLETED | Vitamin K Antagonist Regimen | 175 |
Source ClinicalTrials.gov
Adverse events532
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 | Nasopharyngitis | Infections and infestations | Edoxaban Regimen | 25 | 746 | |
| other | Nasopharyngitis | Infections and infestations | Vitamin K Antagonist Regimen | 22 | 740 | |
| other | Pneumonia | Infections and infestations | Edoxaban Regimen | 20 | 746 | |
| other | Pneumonia | Infections and infestations | Vitamin K Antagonist Regimen | 22 | 740 | |
| other | Bronchitis | Infections and infestations | Edoxaban Regimen | 19 | 746 | |
| other | Bronchitis | Infections and infestations | Vitamin K Antagonist Regimen | 20 | 740 | |
| other | Urinary tract infection | Infections and infestations | Edoxaban Regimen | 14 | 746 | |
| other | Urinary tract infection | Infections and infestations | Vitamin K Antagonist Regimen | 19 | 740 | |
| other | Respiratory tract infection | Infections and infestations | Edoxaban Regimen | 12 | 746 | |
| other | Respiratory tract infection | Infections and infestations | Vitamin K Antagonist Regimen | 15 | 740 |
1 to 10 of 532Source ClinicalTrials.gov
See all 532 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Edoxaban Regimen | 46 | 746 |
| Total, all-cause mortality | Vitamin K Antagonist Regimen | 37 | 740 |
| Total, other adverse events | Edoxaban Regimen | 457 | 746 |
| Total, other adverse events | Vitamin K Antagonist Regimen | 447 | 740 |
| Total, serious adverse events | Edoxaban Regimen | 176 | 746 |
| Total, serious adverse events | Vitamin K Antagonist Regimen | 175 | 740 |
Source ClinicalTrials.gov
Papers3
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 Regimen vs Vitamin K Antagonist Regimen: deaths from any cause | Trial comparisons |
| Edoxaban Regimen vs Vitamin K Antagonist Regimen: 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/NCT02866175
GET https://conductscience.org/api/trials/v1/NCT02866175/results?page=2