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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,653
Number of Participants With Death or First Thromboembolic Event (DTE)
Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.
Time frame: Through study completion, on average 14 months
Number of Participants With Death or First Thromboembolic Event (DTE)
Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.
Time frame: Through study completion, on average 16 months
Number of Participants With Primary Bleeding Event (PBE)
PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.
Time frame: Through study completion, on average 16 months
Number of Participants With Net-clinical Benefit
The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety).
Time frame: Through study completion, on average 16 months
Number of Participants With Cardiovascular Death or Thromboembolic Event
Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).
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In case of NOAF, 20/15 mg OD (once-daily)
In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines
Unnamed facility
Los Angeles, California, United States
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Washington D.C., District of Columbia, United States
Unnamed facility
Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
Unnamed facility
West Des Moines, Iowa, United States
Unnamed facility
Baltimore, Maryland, United States
...and 130 more locations
Time frame: Through study completion, on average 16 months
Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds
Composite of TIMI major and minor bleedings
Time frame: Through study completion, on average 16 months
Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds
ISTH major bleeds
Time frame: Through study completion, on average 16 months
Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds
Composite of BARC 2,3 or 5 bleedings
Time frame: Through study completion, on average 16 months