Last updated on June 2018

Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: peripheral arterial disease | Peripheral vascular disease
  • Age: Between 40 - 90 Years
  • Gender: Male or Female

Pre-screening criteria

  • Laboratory values available 1 year of the date of screening: hemoglobin 9g, platelet count >50,000 mm3 or <600,000 mm3
  • No history of stroke or transient ischemic attack (TIA)
  • No allergy to aspirin
  • 40 years of age
  • Presence of documented PAD by ABI <0.80 at rest or 20% drop in claudication limited exercise ABI in any limb and one of the following criteria in the corresponding limb:

i.Prior surgical and/or endovascular lower extremity intervention (infra-renal aorta to pedal arteries) ii. Known presence of flow-limiting stenosis (70%) by clinically indicated angiography, computed tomographic (CT) or magnetic resonance imaging (MRI) tests or by Duplex ultrasonography (DUS) defined standard clinical criteria in lower extremity arteries

  • Documented IC Rutherford/Becker (RC) category 2
  • Presence of any one of the listed classes of agents [angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), lipid lowering therapy, aspirin and beta-blocker drugs]-No MI or percutaneous coronary intervention (PCI) with DES within the past 11 months
  • No planned surgical or endovascular procedures other than for the treatment of IC for the expected duration of the study
  • No warfarin or other chronic oral anticoagulant use within the last 14 days
  • No use of ticagrelor, clopidogrel, prasugrel or ticlopidine within last 7 days
  • No contraindication(s) to the use of antithrombin or antiplatelet agents (history of intra-cerebral hemorrhage or ICH, presence of intracerebral mass, recent or <12 weeks gastrointestinal bleed requiring blood transfusion, any blood transfusion within the last 6 weeks, any trauma requiring surgery within the last 4 weeks or any surgical or endovascular procedure within the last 4 weeks
  • No use of cilostazol and/or pentoxyphilline within last 7 days
  • Severe psychiatric or behavioral illness that in the judgement of the investigator precludes study participation
  • No history of major or minor amputation
  • Severe heart, vascular and lung disease in the discretion of the investigator that precludes study participation.
  • Ability to walk for at least 15 min/day, at least 3 days/week, at 20 steps/min

Inclusion criteria

  • Treadmill PWT= 2-10 min on Gardner protocol
  • Estimated survival 1 year in the judgment of the site investigator
  • Use of at least one aspirin dose within at least 5 days prior to randomization at 325 mg dose in aspirin nave patients (0-5 days of prior aspirin use) or at least one aspirin dose prior to randomization at 81 mg dose in patients on chronic (>5 days) aspirin therapy (at clinically indicated doses).
  • Presence of any one of the listed classes of agents [angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), lipid lowering therapy, aspirin and beta-blocker drugs]

Exclusion Criteria:

  • MI or percutaneous coronary intervention (PCI) with DES within the past 11 months
  • Positive pregnancy test
  • Planned surgical or endovascular procedures other than for the treatment of IC
  • Warfarin or other chronic oral anticoagulant use within 14 days
  • Use of Ticagrelor, Clopidogrel, Prasugrel or Ticlopidine within 7 days
  • Contraindication(s) to the use of antithrombin or antiplatelet agents (history of intra-cerebral hemorrhage or ICH, presence of intracerebral mass, recent or <12 weeks gastrointestinal bleed requiring blood transfusion, any blood transfusion within the last 6 weeks, any trauma requiring surgery within the last 4 weeks or any surgical or endovascular procedure within the last 4 weeks
  • Use of cilostazol and/or pentoxyphilline within 7 days

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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