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Antiplatelet agent

edoxaban/aspirin for Peripheral Arterial Disease (ePAD Trial)

Phase 2
Waitlist Available
Research Sponsored by Daiichi Sankyo, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months
Awards & highlights

ePAD 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 or without stent placement, relative to current treatment practice with clopidogrel and aspirin.

Eligible Conditions
  • Peripheral Arterial Disease

ePAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Clinically Relevant Bleeding During Treatment
Percentage of Participants With First Re-stenosis / Re-occlusion
Secondary outcome measures
Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period
Amputation
Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment
+1 more

ePAD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: edoxaban/aspirinExperimental Treatment2 Interventions
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.
Group II: clopidogrel/aspirinActive Control2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylsalicylic acid
FDA approved
Edoxaban
FDA approved

Find a Location

Who is running the clinical trial?

Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
420,273 Total Patients Enrolled
UMC UtrechtOTHER
524 Previous Clinical Trials
2,104,168 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
1,864 Patients Enrolled for Peripheral Arterial Disease
Daiichi SankyoLead Sponsor
396 Previous Clinical Trials
418,796 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Edoxaban in Peripheral Arterial Disease
2013. "Edoxaban in Peripheral Arterial Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01802775.
~17 spots leftby May 2025
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