This study is a randomized, open-label, blinded endpoint, parallel-group, active-control, multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD), designed to assess the safety and potential efficacy of adding edoxaban to aspirin following femoropopliteal endovascular intervention, with or without stent placement, relative to current treatment practice with clopidogrel and aspirin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
203
Percentage of Participants With Clinically Relevant Bleeding During Treatment
Percentage of participants with clinically relevant bleeding, defined as major bleeding or clinical relevant non-major bleeding, in the on-treatment period based on International Society of Thrombosis and Haemostasis (ISTH)
Time frame: at 3 months
Percentage of Participants With First Re-stenosis / Re-occlusion
Percentage of participants with re-stenosis/re-occlusion during treatment within 6 months - only the first occurrence of re-stenosis / re-occlusion was counted for each participant
Time frame: within 6 months
Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment
The percentage of participants with major, clinically relevant non-major, and minor bleeding occurring during treatment, within 3 months
Time frame: within 3 months
Safety Assessments
Number of participants with serious adverse events (SAEs) within 6 months Note: Based on changes to the database structure, clinically significant changes in physical or laboratory parameters are recorded as adverse events (AEs). Details of non-serious adverse events are reported at the 5% reporting threshold in the AE module, as is all-cause mortality.
Time frame: within 6 months
Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period
Number of Adjudicated Major Adverse Cardiovascular Events (MACE) which is a composite of non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death
Time frame: within 6 months
Number of Participants With Amputations
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Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
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Beverly Hills, California, United States
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Los Angeles, California, United States
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Orange, California, United States
Unnamed facility
New Haven, Connecticut, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
Unnamed facility
Aurora, Illinois, United States
Unnamed facility
Iowa City, Iowa, United States
...and 32 more locations
Number of participants with amputations within 6 months
Time frame: within 6 months