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)
- Conditions
- 10003216narrowing of the peripheral arteries (mostly in the legs)periferal arterial disease
- Registration Number
- NL-OMON40071
- Lead Sponsor
- Daiichi Sankyo Development Ltd
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
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;
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate clinically relevant bleeding (i.e., major or clinically relevant<br /><br>non-major bleeding) occurring during treatment or within 3 days of<br /><br>interrupting or stopping study drug.<br /><br>- To evaluate re-stenosis/re-occlusion [defined as peak systolic velocity<br /><br>(PSV) ratio >/= 2.4] at the treated segments(s) measured at 1, 3 and 6<br /><br>months after randomization using color coded duplex ultrasonography<br /><br>scanning (DUS).</p><br>
- Secondary Outcome Measures
Name Time Method