Study of new oral anticoagulant (Edoxaban) plus aspirin versus oral antiplatelet (clopidogrel) plus aspirin in PAD patients who have had their vessels opened by intervention to preserve the opened vessel and prevent reocclusion of the treated vessel.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

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 eligible if they have undergone additional successful
endovascular intervention(s) during the index intervention;
8. Able to provide signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. Calculated 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 pre-interventional loading dose of clopidogrel or other P2Y12 receptor antagonists; see Appendix 17.5. for details;
11. Treatment with cilostazol within 24 hours 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]; see Appendix 17.5 for list of prohibited concomitant medications;
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; 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;
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 the subject at increased risk of harm i

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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