Global multicenter, open-label, randomized, event-driven, active-controlled study comparing a rivAroxaban-based antithrombotic strategy to an antipLatelet-based strategy after transcatheter aortIc vaLve rEplacement (TAVR) to Optimize clinical outcomes.
- Conditions
- Heart Valve replacementTranscatheter Aortic Valve Replacement (TAVR)10046973
- Registration Number
- NL-OMON45994
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Key inclusion criteria:
• Successful TAVR of a native aortic valve stenosis (either native of valve-in-valve)
• By iliofemoral or subclavian access
• With any approved/marketed device
• Written informed consent (IC)
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 ongoing absolute indication for dual-antiplatelet therapy (DAPT) at time of screening that is unrelated to the TAVR procedure.
• 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 impairement (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Endpoint: death or first adjudicated thromboembolic event<br /><br>(DTE) defined as the composite of allcause death and adjudicated any stroke,<br /><br>myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism<br /><br>(PE), deep vein thrombosis (DVT), or non-CNS systemic embolism.<br /><br><br /><br>Primary Safety Endpoint: primary bleeding event (PBE) defined as the composite<br /><br>of adjudicated life-threatening, disabling or major bleeding, classified<br /><br>according to the valve academic research consortium (VARC) definitions<br /><br>following the bleeding academic research consortium (BARC) classification.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The composite of TIMI major or minor bleeds<br /><br>ISTH major bleeding<br /><br>The composite of BARC 2, 3, or 5 bleeding</p><br>