Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:December 16, 2015
End Date:November 27, 2018

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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

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
antiplateletbased strategy, following TAVR.


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
We found this trial at
34
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