Trial · NCT02943785
Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
NCT02943785, Phase 3, Completed, Daiichi Sankyo; results first posted 2022-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF). Trials, record NCT02943785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02943785
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
- NCT number
- NCT02943785
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,426 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Atrial Fibrillation
- Interventions
- Edoxaban-based Regimen, VKA-based Regimen
- First posted
- 2016-10-25
- Last updated
- 2022-03-24
- Other registries' IDs
- eudract:2016-003930-26
- Results first posted
- 2022-03-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA | Baseline through study completion, up to 36 months post-dose | 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\]. |
| Primary | Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA | Baseline through study completion, up to 36 months post-dose | ISTH Bleeding Criteria for Major Bleeding are defined as clinically overt bleeding that is associated with: a fall in hemoglobin of 2 g/dL (1.24 mmol/L) or more, or a transfusion of 2 or more units of whole blood or packed red blood cells, or symptomatic bleeding into a critical site or organ such as intracranial, intraspinal, intraocular, retroperitoneal, pericardial, intra-articular, or intramuscular with compartment syndrome, or a fatal outcome. |
| Secondary | Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA | Baseline through study completion, up to 36 months post-dose | The composite endpoint of net adverse event clinical events (NACE) included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding based on Thrombolysis in Myocardial Infarction (TIMI) criteria. Bleeding by TIMI criteria was defined as the following: (1) Major, any intracranial hemorrhage or any clinically overt bleeding, (including bleeding evident in imaging studies) associated with a fall of hemoglobin (Hb) of ≥ 5g/dL or fatal bleeding and (2) Minor, any clinically overt bleeding associated with a fall in Hb ≥ 3g/dL but \< 5 g/dL. |
| Secondary | Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on BARC Type 3 or 5 Criteria in Participants Taking Edoxaban vs VKA | Baseline through study completion, up to 36 months post-dose | The composite endpoint of net adverse event clinical events (NACE) included all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding based on Bleeding Academic Research Consortium (BARC) Type 3 or 5 criteria. Major bleeding by BARC criteria was defined as Type 3: clinical, laboratory, and/or imaging evidence of bleeding with provider responses; Type 3a: any transfusion with overt bleeding; overt bleeding plus Hb drop of 3 to \< 5 g/dL; Type 3b: overt bleeding plus Hb drop ≥ 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention; bleeding requiring intravenous vasoactive drugs; Type 3c: intracranial hemorrhage; subcategories confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision; Type 5: fatal bleeding; Type 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious; Type 5b: definite fatal bleeding; overt bleeding or autopsy or imaging confirmation |
| Secondary | Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on GUSTO Criteria in Participants Taking Edoxaban vs VKA | Baseline through study completion, up to 36 months post-dose | The composite endpoint of net adverse event clinical events (NACE) included all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding based on Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO). GUSTO criteria was defined as the following: severe or life threatening: intracerebral hemorrhage or resulting in substantial hemodynamic compromise requiring treatment and moderate: requiring blood transfusion but not resulting in hemodynamic compromise. |
| Secondary | Number of Participants Who Experienced Major Adverse Cardiac Events (MACE) in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Baseline through study completion, up to 36 months post-dose | Major adverse cardiac events (MACE) is defined as the composite of all-cause death (excluding adjudicated non-cardiac death), MI, or repeat coronary revascularization of the target lesion. |
| Secondary | Number of Participants Who Experienced Major Adverse Cardiac and Cerebrovascular Events (MACCE) in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Baseline through study completion, up to 36 months post-dose | Major adverse cardiac and cerebrovascular events (MACCE) is defined as the composite of all-cause death (excluding adjudicated non-cardiac death), MI, stroke (ischemic, hemorrhagic, or undetermined), or repeat coronary revascularization of the target lesion |
| Secondary | Number of Participants Who Experienced a Composite of Adverse Events in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Baseline through study completion, up to 36 months post-dose | A composite of clinical adverse events included cardiovascular death, MI ischemic stroke, SEE, valve thrombosis, and major bleeding as defined by ISTH criteria. |
| Secondary | Number of Participants Who Experienced Stroke Events (Ischemic, Hemorrhagic, Undetermined) in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Baseline through study completion, up to 36 months post-dose | Stroke events are categorized as any stroke, fatal stroke, and non-fatal stroke. |
| Secondary | Number of Participants Who Experienced Systemic Embolic Events in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Baseline through study completion, up to 36 months post-dose | Systemic thromboembolism \[non-central nervous system\] is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA | Baseline through study completion, up to 36 months post-dose | Net adverse clinical events were assessed in the Intent-to-Treat (ITT) Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA | Baseline through study completion, up to 36 months post-dose | Bleeding events were assessed in the ITT Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA | Baseline through study completion, up to 36 months post-dose | Net adverse clinical events were assessed in the ITT Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on BARC Type 3 or 5 Criteria in Participants Taking Edoxaban vs VKA | Baseline through study completion, up to 36 months post-dose | Net adverse clinical events were assessed in the ITT Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on GUSTO Criteria in Participants Taking Edoxaban vs VKA | Baseline through study completion, up to 36 months post-dose | Net adverse clinical events were assessed in the ITT Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Major Adverse Cardiac Events (MACE) in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Baseline through study completion, up to 36 months post-dose | MACE were assessed in the ITT Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Major Adverse Cardiac and Cerebrovascular Events (MACCE) in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Baseline through study completion, up to 36 months post-dose | MACE were assessed in the ITT Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a Composite of Adverse Events in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Baseline through study completion, up to 36 months post-dose | A composite of adverse events was assessed in the ITT Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Stroke Events (Ischemic, Hemorrhagic, Undetermined) in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Baseline through study completion, up to 36 months post-dose | Stroke events were assessed in the ITT Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Systemic Embolic Events in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Baseline through study completion, up to 36 months post-dose | Systemic embolic events (SEE) were assessed in the ITT Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA | Edoxaban | 170 | Participants | ||
| Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA | Vitamin K Antagonist (VKA) | 157 | Participants | ||
| Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA | Edoxaban | 98 | Participants | ||
| Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA | Vitamin K Antagonist (VKA) | 68 | Participants | ||
| Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA | Edoxaban | Composite endpoint NACE (TIMI) | 154 | Participants | |
| Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA | Vitamin K Antagonist (VKA) | Composite endpoint NACE (TIMI) | 141 | Participants | |
| Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA | Edoxaban | Composite of major and minor bleeding (TIMI) | 72 | Participants | |
| Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA | Vitamin K Antagonist (VKA) | Composite of major and minor bleeding (TIMI) | 42 | Participants | |
| Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on BARC Type 3 or 5 Criteria in Participants Taking Edoxaban vs VKA | Edoxaban | Composite endpoint NACE (BARC Type 3 or 5) | 164 | Participants | |
| Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on BARC Type 3 or 5 Criteria in Participants Taking Edoxaban vs VKA | Vitamin K Antagonist (VKA) | Composite endpoint NACE (BARC Type 3 or 5) | 151 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 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 | 713 | |
| Overall Study | STARTED | Vitamin K Antagonist (VKA) | 713 | |
| Overall Study | COMPLETED | Edoxaban | 431 | |
| Overall Study | COMPLETED | Vitamin K Antagonist (VKA) | 350 | |
| Overall Study | NOT COMPLETED | Edoxaban | 282 | |
| Overall Study | NOT COMPLETED | Vitamin K Antagonist (VKA) | 363 |
Source ClinicalTrials.gov
Adverse events1,054
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 | Urinary tract infection | Infections and infestations | Edoxaban | 63 | 693 | |
| other | Urinary tract infection | Infections and infestations | Vitamin K Antagonist (VKA) | 45 | 684 | |
| other | Pneumonia | Infections and infestations | Edoxaban | 45 | 693 | |
| other | Pneumonia | Infections and infestations | Vitamin K Antagonist (VKA) | 43 | 684 | |
| other | Anaemia | Blood and lymphatic system disorders | Edoxaban | 62 | 693 | |
| other | Anaemia | Blood and lymphatic system disorders | Vitamin K Antagonist (VKA) | 40 | 684 | |
| other | Dizziness | Nervous system disorders | Edoxaban | 47 | 693 | |
| other | Dizziness | Nervous system disorders | Vitamin K Antagonist (VKA) | 33 | 684 | |
| other | Cardiac failure | Cardiac disorders | Edoxaban | 78 | 693 | |
| other | Cardiac failure | Cardiac disorders | Vitamin K Antagonist (VKA) | 85 | 684 |
1 to 10 of 1,054Source ClinicalTrials.gov
See all 1,054 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Edoxaban | 83 | 693 |
| Total, all-cause mortality | Vitamin K Antagonist (VKA) | 78 | 684 |
| Total, other adverse events | Edoxaban | 522 | 693 |
| Total, other adverse events | Vitamin K Antagonist (VKA) | 429 | 684 |
| Total, serious adverse events | Edoxaban | 388 | 693 |
| Total, serious adverse events | Vitamin K Antagonist (VKA) | 372 | 684 |
Source ClinicalTrials.gov
Papers5
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Edoxaban vs Vitamin K Antagonist (VKA): Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA | Trial comparisons |
| Edoxaban vs Vitamin K Antagonist (VKA): Number of Participants Who Experienced Myocardial Infarctions (MI) in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Trial comparisons |
| Edoxaban vs Vitamin K Antagonist (VKA): Number of Participants Who Experienced Major Adverse Cardiac Events (MACE) in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Trial comparisons |
| Edoxaban vs Vitamin K Antagonist (VKA): Number of Participants Who Experienced Major Adverse Cardiac and Cerebrovascular Events (MACCE) in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Trial comparisons |
| Edoxaban vs Vitamin K Antagonist (VKA): Number of Participants Who Experienced Systemic Embolic Events in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Trial comparisons |
| Edoxaban vs Vitamin K Antagonist (VKA): Number of Participants Who Experienced Valve Thrombosis in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Trial comparisons |
| Edoxaban vs Vitamin K Antagonist (VKA): Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA | Trial comparisons |
| Edoxaban vs Vitamin K Antagonist (VKA): deaths from any cause | Trial comparisons |
| Edoxaban vs Vitamin K Antagonist (VKA): Number of Participants Who Experienced a Composite of Adverse Events in Participants Taking Edoxaban vs VKA (Adjudicated Data) | Trial comparisons |
| Edoxaban vs Vitamin K Antagonist (VKA): 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/NCT02943785
GET https://conductscience.org/api/trials/v1/NCT02943785/results?page=2