This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,365
10 mg tablet once daily for 12 months
20 mg tablet once daily for 12 months
100 mg tablet once daily for 12 months
Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
The primary efficacy outcomes (i.e., recurrent venous thromboembolism \[VTE\] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism \[PE\] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Time frame: Up to 12 months, at least 6 months
Number of Participants With First Treatment-emergent Major Bleeding
The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Time frame: Up to 12 months, at least 6 months
Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
Time frame: Up to 12 months, at least 6 months
Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
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Beverly Hills, California, United States
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La Jolla, California, United States
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Ventura, California, United States
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Denver, Colorado, United States
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Jacksonville, Florida, United States
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Columbus, Georgia, United States
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Joliet, Illinois, United States
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Rockport, Maine, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
...and 256 more locations
The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.
Time frame: Up to 12 months, at least 6 months