Edoxaban in Peripheral Arterial Disease (ePAD)
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.
Peripheral Arterial Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- bleeding events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]The proportion of subjects with major, major or clinically relevant non-major and all bleedings at 6 months.
- proportion of patients with re-stenosis/re-occlusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]The difference in proportions of patients with re-stenosis/re-occlusion at the treated segments(s)/s between treatment groups at 6 months.
- bleeding events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]The proportion of subjects with major, major or clinically relevant non-major and all bleedings at 6 months will be estimated for each treatment group and summarized with 95% CI. The difference in the proportion between the two groups at each of the time points will be estimated with a 95% confidence interval (CI).
- any bleeding [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]number of subjects with any bleeding (major, clinically relevant non-major, and minor bleeding) occurring during treatment or within 3 days of interrupting or stopping study drug
- safety assessments [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]number of clinical and laboratory safety events with description of event including adverse events (AEs), serious adverse events (SAEs), and other events of special interest (i.e., hepatic events).
- Major Adverse Cardiovascular Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]number of Major Adverse Cardiovascular Events (MACE) which is a composite of non-fatal myocardial infarction (MI)/non-fatal stroke and death from cardiovascular causes
- amputations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]number of amputations and description of event
- all cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]number of all cause mortalities and description of event
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802775
|Contact: Medpace Recruiting||Recruitment@Medpace.com|
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