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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Peripheral Arterial Disease

In brief

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).

Key facts

Study ID

NCT02660866

Run by

North Texas Veterans Healthcare System

People needed

200

Starts

2016-07-01

Expected to finish

2019-07-01

Last updated by the study team

2018-05-29

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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]

You may not qualify if…

• 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

Where it is running

• Southern Arizona VA Health Care System — Tucson, Arizona, United States (enrolling)
• San Diego VA Medical center — San Diego, California, United States (enrolling)
• VA Eastern Colorado Healthcare System — Denver, Colorado, United States (enrolling)
• Atlanta Heart Specialists — Atlanta, Georgia, United States (enrolling)
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
• Minneapolis VA Medical center — Minneapolis, Minnesota, United States (enrolling)
• Creighton University — Omaha, Nebraska, United States (enrolling)
• Northwell Health — Manhasset, New York, United States (enrolling)
• OKlahoma VA Medical Center — Oklahoma City, Oklahoma, United States (enrolling)
• VA Portland Health Care System — Portland, Oregon, United States (enrolling)
• VA North Texas Health Care System — Dallas, Texas, United States (enrolling)
• Texas Tech University Health Science Center — Lubbock, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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