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-edoxaban in peripheral arterial disease (ePAD) - ePAD

Daiichi Sankyo Development Ltd0 sites14 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

December 2, 2014

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Daiichi Sankyo Development Ltd

•1\. Male or female subjects older than the minimum legal adult age (country specific);
•2\. Rutherford stages 2\-5; provided there are no ulcerations on the heel and/or exposed tendon and/or bone
•3\. Superficial femoral above knee\-popliteal (3 cm proximal to the medial femoral condyle) lesion and \>\= 50% stenosis or occlusion;
•4\. At least one run\-off vessel to the foot with or without additional endovascular intervention
•5\. Successful intervention, defined as angiographic confirmation of \<\= 30% residual stenosis and absence of flow limiting dissection;
•6\. Adequate hemostasis at the vascular access site within 24 hours of intervention;
•7\. A subject is also eligible if they have undergone additional successful endovascular intervention(s) during the index intervention;
•8\. Able to provide signed informed consent.

•1\. Calculated creatinine clearance (CrCL) \<30 ml/min;
•2\. Femoral or popliteal aneurysm;
•3\. Adjunctive use of thrombolytics;
•4\. Any extravasation or distal embolization not successfully treated;
•5\. Uncontrolled hypertension as judged by the investigator (e.g., systolic blood pressure \>170 mmHg or diastolic blood pressure \>100 mmHg despite antihypertensives)
•6\. Aspirin intolerance;
•7\. Clopidogrel intolerance;
•8\. Contraindication for anticoagulants or antiplatelets and any other contraindication listed in the local labeling of aspirin and/or clopidogrel (see Appendix 17\.8 for US and EU labeling);
•9\. Active bleeding or known high risk for bleeding or history of intracranial, or spontaneous intraocular, spinal retroperitoneal or intra\-articular bleeding; overt gastrointestinal (GI) bleeding or
•active ulcer within the previous year;