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

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 4, randomized clinical trial to evaluate whether addition of Vorapaxar 2.08 mg daily vs. placebo daily on background antiplatelet therapy, prescribed for 6 months to patients with established peripheral artery disease (PAD) and Intermittent Claudication (IC) treated with standard medical therapy (SMT) would lead to an improvement in the peak walking time (PWT).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North Texas Veterans Healthcare System
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Enzyme Inhibitors; Thrombin; Vorapaxar

Criteria

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 naïve 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