Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
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|ClinicalTrials.gov Identifier: NCT02943785|
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : May 25, 2018
When the upper chambers of a person's heart receive irregular electrical signals it causes abnormal rhythm in the heart beat. This is called atrial fibrillation.
Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients also get new heart valves using a catheter.
Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is considered the standard care. This study will see how edoxaban compares to VKA in patients who got a new heart valve by using a catheter.
The study will compare the two drugs for up to three years after heart valve replacement, looking at the drug's overall side effects (called adverse events) and major bleeding.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Edoxaban-based Regimen Drug: VKA-based Regimen||Phase 3|
Use of Edoxaban in patients with atrial fibrillation (AF) and indication to chronic oral anticoagulation (OAC) after transcatheter aortic valve implantation (TAVI)
- To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis [ISTH] definition).
- To assess the effect of Edoxaban versus VKA on major bleeding (ISTH definition).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) - in Atrial Fibrillation|
|Actual Study Start Date :||March 21, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Edoxaban-based Regimen
Edoxaban-based regimen 60 mg and 30 mg film coated tablet for once-daily oral use, and 15 mg film coated tablet for transitioning at end of treatment. Dosing must follow the locally approved label.
Drug: Edoxaban-based Regimen
15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed)
Active Comparator: VKA-based Regimen
VKA-based regimen oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator will monitor the patient and adjust the VKA dose to maintain the dose within target.
Drug: VKA-based Regimen
Dosed at International Normalized Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in the country location (with anti-platelet therapy pre-declared at randomization if prescribed).
- Number of participants experiencing the described adverse event composite within 36 months (ISTH definition) [ Time Frame: within 36 months ]Adverse event composite 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].
- Number of participants experiencing major bleeding (ISTH definition) [ Time Frame: within 36 months ]
- Number of participants experiencing the described adverse event composite within 36 months (non-ISTH definition) [ Time Frame: within 36 months ]This adverse event composite included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding per definitions other than those of the International Society on Thrombosis and Haemostasis (ISTH]
- Percentage of participants experiencing major bleeding per other than ISTH definition [ Time Frame: within 36 months ]Other than ISTH definitions include Thrombolysis in Myocardial Infarction (TIMI) and Bleeding Academic Research Consortium (BARC)
- Percentage of participants experiencing stroke (ischemic, hemorrhagic, or undetermined) [ Time Frame: Baseline to 36 months ]Description: Categories will include Any Stroke, Fatal Stroke, Non-fatal Stroke
- Percentage of participants experiencing systemic embolic events (SEE) [ Time Frame: Baseline to 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943785
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|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|