ePADA 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

Date de début de l'étude : 6 février 2013

Inclusion Criteria: Male or female subjects older than the minimum legal adult age (country specific); Rutherford stages 2-5 provided there are no ulcerations on the heel and/or exposed tendon and/or bone; Superficial femoral above knee-popliteal ( 3 cm proximal to the medial femoral condyle) lesion and ≥ 50% stenosis or occlusion; At least one run-off vessel to the foot with or without additional endovascular intervention; Successful intervention, defined as angiographic confirmation of ≤ 30% residual stenosis and absence of flow limiting dissection; Adequate hemostasis at the vascular access site within 24 hours of intervention; A subject is also eligible if they have undergone additional successful endovascular intervention(s) during the index intervention; Able to provide signed informed consent. Exclusion Criteria: Calculated Creatinine Clearance < 30 ml/min; Femoral or popliteal aneurysm; Adjunctive use of thrombolytics; Any extravasation or distal embolization not successfully treated; Uncontrolled hypertension as judged by the investigator (e.g., systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg despite antihypertensives); Aspirin intolerance; Clopidogrel intolerance; Contraindication for anticoagulants or antiplatelets and any other contraindication listed in the local labeling of aspirin and/or clopidogrel; 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; Subjects receiving dual antiplatelet or anticoagulant therapy at the time of randomization; subjects receiving pre-interventional loading dose of clopidogrel or other P2Y12 receptor antagonists; Treatment with cilostazol within 24 hours of randomization; Subjects receiving prohibited concomitant medications [fibrinolytics, chronic use of non steroidal anti-inflammatory drugs (NSAIDS) > 4 days per week, and oral or parenteral non-aspirin NSAIDs and strong P-gp inhibitors]; Prior stroke or myocardial infarction (MI) or acute coronary syndrome within 3 months; Chronic liver disease [alanine transaminase (ALT) and/or aspartate transaminase (AST) ≥ 2 × upper limit of normal; total bilirubin (TBL) ≥ 1.5 × upper limit of normal]; however, subjects whose elevated TBL is due to known Gilbert"s syndrome may be included in the study; Prior history of a positive test for Hepatitis B antigen or Hepatitis C antibody; Subjects who received any investigational drug or device within 30 days prior to randomization, or plan to receive such investigational therapy during the study period; Subjects previously randomized to an edoxaban (DU-176b) study; Women of childbearing potential without proper contraceptive measures (i.e. a method of contraception with a failure rate < 1 % during the course of the study including the observational period) and women who are pregnant or breast feeding; Subjects with the following diagnoses or situations: Active malignancy except for adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g., cervical cancer in situ); Concurrent treatment with cancer therapy (drugs, radiation, and/or surgery); Other significant active concurrent medical illness or infection; Life expectancy < 12 months; Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, and/or otherwise considered by the Investigator to be unlikely to complete the study); Subjects with any condition that, in the opinion of the Investigator, would place the subject at increased risk of harm if he/she participated in the study; History of heparin-induced thrombocytopenia