Edoxaban in Peripheral Arterial Disease (ePAD)
|ClinicalTrials.gov Identifier: NCT01802775|
Recruitment Status : Completed
First Posted : March 1, 2013
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Drug: edoxaban Drug: Clopidogrel Drug: Aspirin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Parallel-Group, Multi-Center Study Of Adding Edoxaban Or Clopidogrel To Aspirin To Maintain Patency In Subjects With Peripheral Arterial Disease Following Femoropopliteal Endovascular Intervention|
|Actual Study Start Date :||February 6, 2013|
|Primary Completion Date :||December 3, 2014|
|Study Completion Date :||December 3, 2014|
Open label edoxaban will be provided. Subjects randomized to this treatment arm will receive edoxaban 60 mg once daily (QD) (two 30 mg tablets) for a total of approximately 3 months on a background of aspirin 100 mg QD.
|Drug: edoxaban Drug: Aspirin|
Active Comparator: clopidogrel/aspirin
Open label clopidogrel will be provided. Subjects randomized to this treatment arm will receive clopidogrel 75 mg QD (one 75 mg tablet) for a total of approximately 3 months on a background of aspirin 100 mg QD. A loading dose of clopidogrel 300 mg (four 75mg tablets) will be given to subjects as the first dose as early as possible after adequate hemostasis (i.e., within 4 hours of hemostasis).
Other Name: PlavixDrug: Aspirin
- Percentage of Participants With Clinically Relevant Bleeding During Treatment [ Time Frame: at 3 months ]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)
- Percentage of Participants With First Re-stenosis / Re-occlusion [ Time Frame: within 6 months ]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
- Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment [ Time Frame: within 3 months ]The percentage of participants with major, clinically relevant non-major, and minor bleeding occurring during treatment, within 3 months
- Safety Assessments [ Time Frame: within 6 months ]
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.
- Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period [ Time Frame: within 6 months ]Number of Adjudicated Major Adverse Cardiovascular Events (MACE) which is a composite of non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death
- Number of Participants With Amputations [ Time Frame: within 6 months ]Number of participants with amputations within 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802775
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|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|