Overview
Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
Status:
Terminated
Terminated
Trial end date:
2018-11-27
2018-11-27
Target enrollment:
0
0
Participant gender:
All
All
Summary
To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE). To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
BayerCollaborator:
Janssen Research & Development, LLCTreatments:
Aspirin
Clopidogrel
Rivaroxaban
Vitamin K
Criteria
Inclusion Criteria:- 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
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 impairment (Child-Pugh Class B or C) or any hepatic
disease associated with coagulopathy