Brief Title
Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation
Official Title
Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation
Brief Summary
A single-center, investigator-initiated, single arm interventional study in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical Center in Rotterdam (NL). Study population will be patients undergoing TAVR with no formal indication for oral anticoagulant (OAC) and no dual antiplatelet therapy (DAPT) requirement for coronary stents. Primary endpoint is the incidence of leaflet thickening on MSCT after three months of edoxaban treatment.
Detailed Description
Rationale: Thromboembolic- and bleeding events can occur after TAVI and can have great consequences. There is currently no evidence-based guideline on prevention of thromboembolic events after TAVI and the current standard of care with DAPT 3-6 months is based on expert opinion. Recently multislice computed tomography (MSCT) studies identified bioprosthesis leaflet thickening and impaired leaflet motion after TAVI. The goal of this study is to investigate whether in TAVI patients, treatment with edoxaban leads to a reduction in leaflet thickening incidence after 3 months and whether it is safe and clinically efficient. Objective: To investigate whether treatment with edoxaban leads to a decrease in incidence of leaflet thickening and is clinical efficient and safe. Study design: A single-center, investigator-initiated, open-label, observational study. Study population: Patients undergoing transfemoral transcatheter aortic valve replacement in the Erasmus University Medical Center with no formal novel oral anticoagulants/vitamin-K-antagonist (NOAC/VKA) indication. Intervention (if applicable): Patients will be treated with edoxaban for a period of 3 months following TAVI. Afterwards they will switch to acetylsalicylic acid. Main study parameters/endpoints: The incidence of leaflet thickening on MSCT 3 months after TAVI and edoxaban treatment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Thus far edoxaban has proven to be safe and non-inferior to treatment with warfarin in several indications. The role of anticoagulant agents in TAVI still has to be unravelled. Subjects participating in this trial are possibly at higher risk for bleeding complications than patients being treated with dual antiplatelet therapy after TAVI.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incidence of aortic valve leaflet thickening after TAVI as assessed by cardiac 4D computed tomography scan (4DCT)
Condition
Aortic Valve Stenosis
Intervention
Edoxaban
Study Arms / Comparison Groups
Edoxaban
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
August 1, 2019
Completion Date
February 1, 2021
Primary Completion Date
January 1, 2021
Eligibility Criteria
Inclusion Criteria: - Completed successful elective TAVI for severe native aortic valve stenosis with any commercially-available transcatheter heart valve (THV). - Correct positioning of a single prosthetic heart valve - Device success, defined by: - Mean aortic valve gradient < 20 mmHg - Peak transvalvular velocity < 3.0 m/s - Aortic valve regurgitation of 2 or less - No periprocedural complications. - No overt stroke - No uncontrolled bleeding - No major vascular complication defined by the Valve academic research committee 2 (VARC-2) consensus - No formal indication for oral anticoagulation - Prevention of thromboembolic complications in patients with atrial fibrillation - Prevention for recurrent venous thromboembolism - Prevention for recurrent pulmonary embolism Exclusion Criteria: - History of life-threatening or major bleeding event ≥ Bleeding academic research committee (BARC) 3b definitions within the last year. - Conditions with a high risk of bleeding - Active peptic ulcer or upper gastrointestinal bleeding (< 3 months) - Malignancy with high risk of bleeding - Recent unresolved brain of spinal injury - Spinal or ophthalmic surgery within last 3 months prior to enrolment - Intracranial haemorrhage - Esophagal varices - Arteriovenous malformations with high risk of bleeding - Vascular aneurysms - Major intraspinal or intracerebral vascular abnormalities - Hypersensitivity or contraindications to edoxaban - No percutaneous coronary intervention within 6 months prior to randomization (requiring DAPT after TAVR) - Dialysis-dependency or glomerular filtration rate < 30 mL/min at time of enrollment - Active bleeding or bleeding diathesis including thrombocytopenia (platelet count < 50.000 cells/UL), thromboasthenia, haemophilia or von Willebrand disease - Patients unable to adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life-threatening disease - Pregnant or breast-feeding subjects - Current participation in clinical trials that potentially interfere with the current study
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +31(0)107035260, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT04171726
Organization ID
REDOX TAVI
Responsible Party
Principal Investigator
Study Sponsor
Erasmus Medical Center
Collaborators
Daiichi Sankyo, Inc.
Study Sponsor
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Verification Date
November 2019