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Peripheral Arterial DiseasePhase 2ePADNCT01802775

Edoxaban in Peripheral Arterial Disease

A Phase 2 study testing edoxaban, Clopidogrel and Aspirin in people with Peripheral Arterial Disease, run by Daiichi Sankyo at 42 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
edoxaban, Clopidogrel and Aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
42 sitesin 7 countries
Study dates
6 Feb 2013to 3 Dec 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 23Show fewer
  • 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

Trial locations and contacts

42 sites in 7 countries.

42 sites in 7 countries

United States26 sites

  • Study site

    Aurora, Illinois

  • Study site

    Austin, Texas

  • Study site

    Beverly Hills, California

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Camp Hill, Pennsylvania

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Flint, Michigan

  • Study site

    Greenville, South Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Iowa City, Iowa

  • Study site

    Jacksonville, Florida

  • Study site

    Lewiston, Maine

  • Study site

    Los Angeles, California

  • Study site

    New Haven, Connecticut

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Orange, California

  • Study site

    Phoenix, Arizona

  • Study site

    Raleigh, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    Teaneck, New Jersey

  • Study site

    Wilmington, North Carolina

  • Study site

    Ypsilanti, Michigan

Other trials in United States

Israel4 sites

  • Study site

    Afula

  • Study site

    Jerusalem

  • Study site

    Tel Aviv

  • Study site

    Tel Litwinsky

Other trials in Israel

Austria3 sites

  • Study site

    Graz

  • Study site

    Innsbruck

  • Study site

    Vienna

Other trials in Austria

Belgium3 sites

  • Edgem

    Edegem

  • Study site

    Ghent

  • Study site

    Leuven

Other trials in Belgium

Germany2 sites

  • Study site

    Bad Krozingen

  • Study site

    Leipzig

Other trials in Germany

Netherlands2 sites

  • Study site

    Rotterdam

  • Study site

    Utrecht

Other trials in Netherlands

Switzerland2 sites

  • Study site

    Bern

  • Study site

    Zurich

Other trials in Switzerland

About this study

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

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.

Being tested
edoxaban, Clopidogrel, Aspirin
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01802775
Study groupRoleWhat they receive
edoxaban/aspirinExperimentalOpen 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.
Receives: Drug: edoxaban; Drug: Aspirin
clopidogrel/aspirinActive comparatorOpen 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).
Receives: Drug: Clopidogrel; Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Clinically Relevant Bleeding During Treatment

    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)

    Measured: at 3 months

  2. Percentage of Participants With First Re-stenosis / Re-occlusion

    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

    Measured: within 6 months

Secondary outcomes (4)

  1. Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment

    The percentage of participants with major, clinically relevant non-major, and minor bleeding occurring during treatment, within 3 months

    Measured: within 3 months

  2. Safety Assessments

    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.

    Measured: within 6 months

  3. Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period

    Number of Adjudicated Major Adverse Cardiovascular Events (MACE) which is a composite of non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death

    Measured: within 6 months

  4. Number of Participants With Amputations

    Number of participants with amputations within 6 months

    Measured: within 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2013 (estimated)
  2. Study start6 Feb 2013
  3. Primary completion3 Dec 2014
  4. Study completion3 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01802775
Sponsor's protocol ID
DU176b-E-U210
Other IDs
2012-003009-88
Acronym
ePAD
Status last verified
Jan 2018
First submitted
25 Feb 2013
Last updated
26 Feb 2019
Data monitoring committee
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. 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://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Moll F, Baumgartner I, Jaff M, Nwachuku C, Tangelder M, Ansel G, Adams G, Zeller T, Rundback J, Grosso M, Lin M, Mercur MF, Minar E; ePAD Investigators. Edoxaban Plus Aspirin vs Dual Antiplatelet Therapy in Endovascular Treatment of Patients With Peripheral Artery Disease: Results of the ePAD Trial. J Endovasc Ther. 2018 Apr;25(2):158-168. doi: 10.1177/1526602818760488.

    PubMed 29552984

  • Tangelder MJ, Nwachuku CE, Jaff M, Baumgartner I, Duggal A, Adams G, Ansel G, Grosso M, Mercuri M, Shi M, Minar E, Moll FL. A review of antithrombotic therapy and the rationale and design of the randomized edoxaban in patients with peripheral artery disease (ePAD) trial adding edoxaban or clopidogrel to aspirin after femoropopliteal endovascular intervention. J Endovasc Ther. 2015 Apr;22(2):261-8. doi: 10.1177/1526602815574687.

    PubMed 25809373

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing edoxaban, Clopidogrel and Aspirin in people with Peripheral Arterial Disease, run by Daiichi Sankyo at 42 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Israel, Austria, Belgium, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Clinically Relevant Bleeding During Treatment (time frame: at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01802775, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.

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Edoxaban in Peripheral Arterial Disease (NCT01802775) | AzTrials