To investigate whether treatment with edoxaban leads to a decrease in incidence of leaflet thickening and is clinical efficient and safe.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate whether edoxaban affects the incidence of aortic valve leaflet
thickening after TAVI as assessed by cardiac 4DCT-scan after 3 months
treatment.
Secondary outcome
To investigate the occurrence of reduced THV leaflet motion by MSCT at 3
months of follow up.
To investigate whether treatment with edoxaban affects transprosthetic
gradients (i.e. change in transprosthetic gradient, effective orifice area and
doppler velocity index between TTE at discharge and at 1 year) after TAVI.
The occurrence and increase of aortic regurgitation as determined by
transthoracic echocardiography pre-discharge and at 12 months.
To investigate the safety of edoxaban treatment in patients undergoing TAVI
-with no formal OAC indication- on net adverse clinical outcomes after 1 month,
3 months and one year; i.e.: the composite of all-cause death, myocardial
infarction (MI), ischemic stroke, systemic thromboembolism, valve thrombosis
and major bleeding (International Society on Thrombosis and Hemostasis [ISTH]
definition) and every endpoint separately including any neurological event
(minor/disabling stroke and TIA)
To investigate the effect of edoxaban treatment in patients undergoing TAVI
-with no formal OAC indication- on major bleeding at 1 month, 3 months and one
year.
Background summary
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.
Study 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, sponsored, open-label, observational
study.
Intervention
Patients will be treated with edoxaban for a period of 3 months following TAVI.
Afterwards they will switch to standard acetylsalicylic acid.
Study burden and risks
Thusfar 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.
Doctor Molenwaterplein 40
Rotterdam 3015 GD
NL
Doctor Molenwaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Patients completed successful elective TAVI for severe aortic valve stenosis
with any commercially-available transcatheter heart valve (THV).
-Correct positioning of a single prosthetic heart valve into the proper
anatomical location
-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 VARC-3 consensus, No formal
indication for oral anticoagulation
- No cardiac structural complication defined by the VARC-3 consensus
- 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 >= BARC 3b definitions
within the last year
Other conditions with a high risk of bleeding
- Active peptic ulcer or upper gastrointestinal bleeding within last 3 months
prior to enrolment
- 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
- Atriovenous malformations with high risk of bleeding
- Vascular aneurysms
- Major intraspinal or intracerebral vascular abnormalities
Hypersensitivity or contraindications to edoxaban
Requirement for dual-antiplatelet therapy (DAPT) within 1 month prior to
enrolment
Concomitant percutaneous coronary intervention (PCI) during the TAVI procedure,
requiring DAPT after the procedure.
Renal impairment defined as by dialysis-dependency or GFR < 30 mL/min at
time of enrollment
Active bleeding or bleeding diasthesis including thrombocytopenia (platelet
count < 50.000 cells/UL), thrombobasthenia, 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
condtition or life-threatening disease
Pregnant or breast-feeding subjects
Current participation in clinical trials that potentially interfere with the
current study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-001425-26-NL |
| CCMO | NL69611.078.19 |