Aortic valve replacment Z95.2
Conditions
Interventions
Group 1: Rivaroxaban-based strategy
• Rivaroxaban 10 mg once-daily AND Acetylsalicylic Acid (ASA) 75-100 mg once-daily
• Rivaroxaban 10 mg once-daily
Whether Rivaroxaban is given alone or in combinati
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Key inclusion criteria: • Successful TAVR of a native aortic valve stenosis • By iliofemoral or subclavian access • With any approved/marketed device • Written informed consent (IC)
Exclusion criteria
Exclusion criteria: Key exclusion criteria: • Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment • Any other indication for continued treatment with any oral anticoagulant (OAC) • Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count = 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma) • Any indication for dual-antiplatelet therapy (DAPT) for more than 3 months after randomization (such as coronary, carotid or peripheral stent implantation) • Clinically overt stroke within the last 3 months • Planned coronary or vascular intervention or major surgery • Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher • Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy. Screening, IC and randomization: Subjects are screened for inclusion after TAVR. Consenting subjects must be randomized within 2-7 days (1-7 days after protocol amendment) after a successful TAVR and before hospital discharge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary comparison will be to test the superiority of a rivaroxaban-based strategy to an antiplatelet-based strategy with respect to the primary efficacy endpoint. This comparison is preceded by a non-inferiority test that must be satisfied. Further, non-inferiority of a rivaroxaban-based strategy to an antiplatelet-based strategy towards the primary safety endpoint will be tested. Primary Efficacy Endpoint: death or first adjudicated thromboembolic event (DTE) defined as the composite of all-cause death and adjudicated any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), or non-CNS systemic embolism. Primary Safety Endpoint: primary bleeding event (PBE) defined as the composite of adjudicated life-threatening, disabling or major bleeding, classified according to the valve academic research consortium (VARC) definitions following the bleeding academic research consortium (BARC) classification. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy objectives are to compare the effects of the rivaroxaban-based strategy and antiplatelet-based strategy with respect to the net-clinical-benefit, defined as the composite of death or first thromboembolic events and life-threatening, disabling, or major bleeding events classified according to the VARC definitions following the BARC classification. Whereas the secondary safety objectives are safety criteria with respect to bleeding (thrombolysis in myocardial infarction [TIMI] major or minor bleeds, international society on thrombosis and haemostasis [ISTH] major bleeding, and BARC 2, 3, or 5 bleeds). | — |
Countries
Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactSanne Rijnders
Cardialysis
Outcome results
None listed