The purpose of the ANT-006 study is to evaluate the bleeding profile of abelacimab relative to rivaroxaban in patients with atrial fibrillation (AF) at moderate-to-high risk of stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
1,287
Abelacimab provided as liquid in vial (150 mg/mL)
Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events
The number of participants experiencing the first occurrence of the composite of ISTH-defined major bleeding or CRNM bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.
Time frame: Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.
Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events
The number of participants experiencing the first occurrence of ISTH-defined major bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.
Time frame: Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.
Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events
The number of participants experiencing the first occurrence of the composite of ISTH-defined major or CRNM or minor bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.
Time frame: Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.
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Anthos Investigative Site
Huntsville, Alabama, United States
Anthos Investigative Site
Mobile, Alabama, United States
Anthos Investigative Site
Stamford, Connecticut, United States
Anthos Investigative Site
Clearwater, Florida, United States
Anthos Investigative Site
Daytona Beach, Florida, United States
Anthos Investigative Site
Largo, Florida, United States
Anthos Investigative Site
Safety Harbor, Florida, United States
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Saint Augustine, Florida, United States
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Johns Creek, Georgia, United States
Anthos Investigative Site
Owensboro, Kentucky, United States
...and 82 more locations