Evaluation of heartvalve leaflet thickening whilst using edoxaban after catheter based aortic valve replacement

Phase 1

• Conditions: aortic stenosis; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-001425-26-NL
• Lead Sponsor: Thoraxcentrum Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-24
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Patients completed successful elective TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV).
oCorrect positioning of a single prosthetic heart valve into the proper anatomical location
oDevice 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
oNo overt stroke
oNo uncontrolled bleeding
oNo major vascular complication defined by the VARC-3 consensus
oNo cardiac structural complication defined by the VARC-3 consensus
•No formal indication for oral anticoagulation
oPrevention of thromboembolic complications in patients with atrial fibrillation
oPrevention for recurrent venous thromboembolism
oPrevention for recurrent pulmonary embolism
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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
oActive peptic ulcer or upper gastrointestinal bleeding within last 3 months prior to enrolment
oMalignancy with high risk of bleeding
oRecent unresolved brain of spinal injury
oSpinal or ophthalmic surgery within last 3 months prior to enrolment
oIntracranial haemorrhage
oEsophagal varices
oAtriovenous malformations with high risk of bleeding
oVascular aneurysms
oMajor intraspinal or intracerebral vascular abnormalities
•Hypersensitivity or contraindications to edoxaban
•Requirement for dual-antiplatelet therapy (DAPT) within 1 month prior to randomization.
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified