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 |
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.
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
sites
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