Atrial FibrillationEMIT-AF/VTENCT02950168
Edoxaban Management in Diagnostic and Therapeutic Procedures
An observational study of Atrial Fibrillation and Venous Thromboembolism, run by Daiichi Sankyo.
Trial summary
Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for short periods of NOAC interruption without heparin bridging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Venous Thromboembolism
- What is being tested?
- Edoxaban
- Type of treatment
- Surgery or procedure
- How many people
- 1,197 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 26 Jul 2018
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Edoxaban-treated patients with NVAF, VAT or PE undergoing planned or unplanned diagnostic or interventional procedures
Who may be able to join
- Patients taking edoxaban for a therapeutic indication for edoxaban according to SMPC including NVAF, DVT or PE
- Patients with a planned or unplanned diagnostic or therapeutic procedure
- Written informed consent
- Availability of patients for follow-up by telephone by the site
- No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible)
Who cannot join
- None
About this study
Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for short periods of NOAC interruption without heparin bridging. There is only minimal information on the peri-procedural usage pattern of edoxaban and the related outcome data currently available. Therefore, further real-world clinical data on the peri-procedural usage pattern of edoxaban within any diagnostic or interventional procedure in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) will be collected in this registry.
Read the detailed description
Patients treated with edoxaban and with a planned or unplanned diagnostic or interventional procedure will be enrolled in this study in order to evaluate the peri-procedural dosing of edoxaban in patients with diagnostic or therapeutic procedures and collect details of the type diagnostic or therapeutic procedures. Patients from 7 different countries and care settings (primary care, secondary care, and different medical specialties) will be enrolled. The study will last until approximately 2000 procedures have been documented, e.g., until about 2000 participants are enrolled, which is expected to take approximately 2.5 years. Any relevant diagnostic or interventional procedure reported will be collected and documented in the electronic case report form (eCRF). Patients will be followed for 30 days after the procedure.
- Conditions
- Atrial Fibrillation, Venous Thromboembolism
- Being tested
- Edoxaban
- Keywords
- Diagnostic procedures, Interventional procedures, Planned or unplanned, Edoxaban-treated population
- Medical subject headings
- Atrial Fibrillation, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanProcedure or surgery
Also called Lixiana
Edoxaban according to Summary of Product Characteristic (SMPC)
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban | All patients treated with edoxaban with a planned or unplanned diagnostic or interventional procedure Receives: Procedure: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with major bleeding within 30 days after a planned or unplanned procedure
Measured: within 30 days after a procedure
Percentage of participants with clinically-significant non-major bleeding (CRNMB) within 30 days after a planned or unplanned procedure
Categories: minor bleeding, all bleeding, and death from any cause
Measured: within 30 days after a procedure
Secondary outcomes (1)
Percentage of participants with acute coronary syndromes within 30 days after a planned or unplanned procedure
Categories: unstable angina pectoris, myocardial infarction, non-haemorrhagic stroke, transient ischaemic attack (TIA), systemic embolism (SEE), deep vein thrombosis (DVT), pulmonary embolism (PE) and cardiovascular (CV) mortality
Measured: within 30 days after a procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,197 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950168
- Sponsor's protocol ID
- DSE-EDO-02-15-EU
- Acronym
- EMIT-AF/VTE
- Status last verified
- Feb 2020
- First submitted
- 28 Oct 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Publications
Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.
PubMed 24251359Vranckx P, Valgimigli M, Eckardt L, Tijssen J, Lewalter T, Gargiulo G, Batushkin V, Campo G, Lysak Z, Vakaliuk I, Milewski K, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Goette A. Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial. Lancet. 2019 Oct 12;394(10206):1335-1343. doi: 10.1016/S0140-6736(19)31872-0. Epub 2019 Sep 3.
PubMed 31492505Unverdorben M, Colonna P, Jin J, Kohler S, Santamaria A, Saxena M, Borrow A, Chen C, von Heymann C, Vanassche T. Periprocedural Edoxaban Management and Clinical Outcomes in Patients Undergoing Transcatheter Cardiovascular Procedures in the EMIT-AF/VTE Program. Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241260728. doi: 10.1177/10760296241260728.
PubMed 38881370von Heymann C, Unverdorben M, Colonna P, Santamaria A, Saxena M, Vanassche T, Kohler S, Borrow AP, Jin J, Chen C. Management of edoxaban therapy and clinical outcomes in patients undergoing major or nonmajor surgery: a subanalysis of the EMIT-AF/VTE study. Thromb J. 2023 Dec 14;21(1):124. doi: 10.1186/s12959-023-00568-2.
PubMed 38098072Santamaria A, Chen C, Colonna P, von Heymann C, Saxena M, Vanassche T, Jin J, Unverdorben M. Predictive Factors and Clinical Events Associated with Edoxaban Interruption and Heparin Bridging Strategy: EMIT-AF/VTE. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231200223. doi: 10.1177/10760296231200223.
PubMed 37697813Unverdorben M, von Heymann C, Santamaria A, Saxena M, Vanassche T, Jin J, Laeis P, Wilkins R, Chen C, Colonna P. Elderly patients with atrial fibrillation in routine clinical practice-peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study. BMC Cardiovasc Disord. 2020 Dec 1;20(1):504. doi: 10.1186/s12872-020-01766-w.
PubMed 33256590
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edoxaban Management in Diagnostic and Therapeutic Procedures
- ClinicalTrials.gov ID
- NCT02950168
- Acronym / sponsor ID
- EMIT-AF/VTE / DSE-EDO-02-15-EU
- Conditions
- Atrial Fibrillation, Venous Thromboembolism
- Keywords
- Diagnostic procedures, Interventional procedures, Planned or unplanned, Edoxaban-treated population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,197 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for short periods of NOAC interruption without heparin bridging. There is only minimal information on the peri-procedural usage pattern of edoxaban and the related outcome data currently available. Therefore, further real-world clinical data on the peri-procedural usage pattern of edoxaban within any diagnostic or interventional procedure in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) will be collected in this registry.
Detailed description
Patients treated with edoxaban and with a planned or unplanned diagnostic or interventional procedure will be enrolled in this study in order to evaluate the peri-procedural dosing of edoxaban in patients with diagnostic or therapeutic procedures and collect details of the type diagnostic or therapeutic procedures. Patients from 7 different countries and care settings (primary care, secondary care, and different medical specialties) will be enrolled. The study will last until approximately 2000 procedures have been documented, e.g., until about 2000 participants are enrolled, which is expected to take approximately 2.5 years. Any relevant diagnostic or interventional procedure reported will be collected and documented in the electronic case report form (eCRF). Patients will be followed for 30 days after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edoxaban | – | Procedure: EdoxabanAll patients treated with edoxaban with a planned or unplanned diagnostic or interventional procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Edoxaban-treated patients with NVAF, VAT or PE undergoing planned or unplanned diagnostic or interventional procedures
Key inclusion criteria (5 listed)
- Patients taking edoxaban for a therapeutic indication for edoxaban according to SMPC including NVAF, DVT or PE
- Patients with a planned or unplanned diagnostic or therapeutic procedure
- Written informed consent
- Availability of patients for follow-up by telephone by the site
- No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanAlso: LixianaEdoxaban according to Summary of Product Characteristic (SMPC) | Procedure or surgery | Edoxaban |
Primary outcome
Percentage of participants with major bleeding within 30 days after a planned or unplanned procedure
Time frame: within 30 days after a procedure
Percentage of participants with clinically-significant non-major bleeding (CRNMB) within 30 days after a planned or unplanned procedure
Time frame: within 30 days after a procedure
Categories: minor bleeding, all bleeding, and death from any cause
1 secondary outcome
Percentage of participants with acute coronary syndromes within 30 days after a planned or unplanned procedure
Time frame: within 30 days after a procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 24251359Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.
- Results publication: PubMed 31492505Vranckx P, Valgimigli M, Eckardt L, Tijssen J, Lewalter T, Gargiulo G, Batushkin V, Campo G, Lysak Z, Vakaliuk I, Milewski K, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Goette A. Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial. Lancet. 2019 Oct 12;394(10206):1335-1343. doi: 10.1016/S0140-6736(19)31872-0. Epub 2019 Sep 3.
- Derived from this study: PubMed 38881370Unverdorben M, Colonna P, Jin J, Kohler S, Santamaria A, Saxena M, Borrow A, Chen C, von Heymann C, Vanassche T. Periprocedural Edoxaban Management and Clinical Outcomes in Patients Undergoing Transcatheter Cardiovascular Procedures in the EMIT-AF/VTE Program. Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241260728. doi: 10.1177/10760296241260728.
- Derived from this study: PubMed 38098072von Heymann C, Unverdorben M, Colonna P, Santamaria A, Saxena M, Vanassche T, Kohler S, Borrow AP, Jin J, Chen C. Management of edoxaban therapy and clinical outcomes in patients undergoing major or nonmajor surgery: a subanalysis of the EMIT-AF/VTE study. Thromb J. 2023 Dec 14;21(1):124. doi: 10.1186/s12959-023-00568-2.
- Derived from this study: PubMed 37697813Santamaria A, Chen C, Colonna P, von Heymann C, Saxena M, Vanassche T, Jin J, Unverdorben M. Predictive Factors and Clinical Events Associated with Edoxaban Interruption and Heparin Bridging Strategy: EMIT-AF/VTE. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231200223. doi: 10.1177/10760296231200223.
- Derived from this study: PubMed 33256590Unverdorben M, von Heymann C, Santamaria A, Saxena M, Vanassche T, Jin J, Laeis P, Wilkins R, Chen C, Colonna P. Elderly patients with atrial fibrillation in routine clinical practice-peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study. BMC Cardiovasc Disord. 2020 Dec 1;20(1):504. doi: 10.1186/s12872-020-01766-w.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Venous Thromboembolism, run by Daiichi Sankyo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with major bleeding within 30 days after a planned or unplanned procedure (time frame: within 30 days after a procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02950168, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.