Status:
COMPLETED
Edoxaban in Peripheral Arterial Disease
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
UMC Utrecht
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a randomized, open-label, blinded endpoint, parallel-group, active-control, multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD), designed to assess th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 6 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2014
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT01802775
Start Date
February 6 2013
End Date
December 3 2014
Last Update
February 26 2019
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States
2
Phoenix, Arizona, United States
3
Beverly Hills, California, United States
4
Los Angeles, California, United States