Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
With
Janssen Research & Development, LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Successful TAVR (Transcatheter Aortic Valve Replacement) of an aortic valve stenosis (either native or valve-in-valve)
* By iliofemoral or subclavian access
* With any approved/marketed device
You may not be if
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 impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
Clareo Health | Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
