NL-OMON40071已完成2 期
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 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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;
- •10. Subjects receiving dual antiplatelet or anticoagulant therapy at the time of randomization; subjects receiving preinterventional loading dose of clopidogrel or other P2Y12 receptor antagonists;
- •11. Treatment with cilostazol within 24h of randomization
- •12. 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];
- •13. Prior stroke or MI or acute coronary syndrome within 3 months;
- •14. Chronic liver disease [alanine transaminase (ALT) and/or aspartate transaminase (AST) >=
- •2 × upper limit of normal (ULN); total bilirubin (TBL) >= 1.5 ×ULN]; however, subjects whose elevated TBL is due to known Gilbert*s syndrome may be included in the study;
- •15. Prior history of a positive test for Hepatitis B antigen or Hepatitis C antibody;
- •16. 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;
- •17. Subjects previously randomized to an edoxaban (DU-176b) study;
- •18. 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;
- •Note: These methods of contraception according to the note for guidance on nonclinical
- •safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and
- •injectables, combined oral contraceptives, hormone containing intrauterine devices,
- •surgical sterilization, sexual abstinence, and vasectomy for the male partner;
- •19. 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;
- •20. 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);
- •21. Subjects with any condition that, in the opinion of the Investigator, would place thesubject at increased risk of harm if he
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