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Edoxaban in Peripheral Arterial Disease (ePAD)

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ClinicalTrials.gov Identifier: NCT01802775
Recruitment Status : Completed
First Posted : March 1, 2013
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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 the safety and potential efficacy of adding edoxaban to aspirin following femoropopliteal endovascular intervention, with or without stent placement, relative to current treatment practice with clopidogrel and aspirin.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: edoxaban Drug: Clopidogrel Drug: Aspirin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 6, 2013
Actual Primary Completion Date : December 3, 2014
Actual Study Completion Date : December 3, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: edoxaban/aspirin
Open label edoxaban will be provided. Subjects randomized to this treatment arm will receive edoxaban 60 mg once daily (QD) (two 30 mg tablets) for a total of approximately 3 months on a background of aspirin 100 mg QD.
Drug: edoxaban Drug: Aspirin
Active Comparator: clopidogrel/aspirin
Open label clopidogrel will be provided. Subjects randomized to this treatment arm will receive clopidogrel 75 mg QD (one 75 mg tablet) for a total of approximately 3 months on a background of aspirin 100 mg QD. A loading dose of clopidogrel 300 mg (four 75mg tablets) will be given to subjects as the first dose as early as possible after adequate hemostasis (i.e., within 4 hours of hemostasis).
Drug: Clopidogrel
75mg tablet
Other Name: Plavix
Drug: Aspirin



Primary Outcome Measures :
  1. Percentage of Participants With Clinically Relevant Bleeding During Treatment [ Time Frame: at 3 months ]
    Percentage of participants with clinically relevant bleeding, defined as major bleeding or clinical relevant non-major bleeding, in the on-treatment period based on International Society of Thrombosis and Haemostasis (ISTH)

  2. Percentage of Participants With First Re-stenosis / Re-occlusion [ Time Frame: within 6 months ]
    Percentage of participants with re-stenosis/re-occlusion during treatment within 6 months - only the first occurrence of re-stenosis / re-occlusion was counted for each participant


Secondary Outcome Measures :
  1. Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment [ Time Frame: within 3 months ]
    The percentage of participants with major, clinically relevant non-major, and minor bleeding occurring during treatment, within 3 months

  2. Safety Assessments [ Time Frame: within 6 months ]

    Number of participants with serious adverse events (SAEs) within 6 months

    Note: Based on changes to the database structure, clinically significant changes in physical or laboratory parameters are recorded as adverse events (AEs). Details of non-serious adverse events are reported at the 5% reporting threshold in the AE module, as is all-cause mortality.


  3. Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period [ Time Frame: within 6 months ]
    Number of Adjudicated Major Adverse Cardiovascular Events (MACE) which is a composite of non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death

  4. Number of Participants With Amputations [ Time Frame: within 6 months ]
    Number of participants with amputations within 6 months



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802775


  Show 42 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
UMC Utrecht
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01802775     History of Changes
Other Study ID Numbers: DU176b-E-U210
2012-003009-88 ( EudraCT Number )
First Posted: March 1, 2013    Key Record Dates
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States and the European Union from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Edoxaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents