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



Status:Recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - 90
Updated:5/30/2018
Start Date:July 2016
End Date:July 2019
Contact:Ishita Tejani, BDS, MS, MSPH
Email:ishita.tejani@va.gov
Phone:214-857-3048

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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).

Primary trial objective: 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 PAD and IC treated with standard medical therapy (SMT) would lead to an
improvement in the peak walking time (PWT)

Study endpoints Primary endpoint: Change from baseline to 6 months in the PWT on a graded
treadmill test (GTT per Gardner protocol) between participants enrolled in the test and
control arms of the study

Secondary endpoints

- Change from baseline to 6 months in the claudication onset time (COT) on GTT between
participants enrolled in the test and control arms of the study.

- Change from baseline to 6 months in the walking impairment questionnaire distance scores
(WIQ) between participants enrolled in the test and control arms of the study.

- Change from baseline to 6 months in self-reported quality of life score using the
Medical Outcomes Study 12-Item Short form survey (SF-12) between participants enrolled
in the test and control arms of the study

Tertiary endpoints

- The first occurrence of clinically indicated lower extremity endovascular or surgical
revascularization procedure during the entire study duration post-randomization in
participants enrolled in the test or control arms of the study.

- The first occurrence of all-cause death, MI, ischemic stroke during the entire study
duration post-randomization in participants enrolled in the test or control arms of the
study.

- The first occurrence of severe bleeding defined according to the Global Utilization of
Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO)
classification during the entire study duration post-randomization in participants
enrolled in the test or control arms of the study.

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
We found this trial at
12
sites
1468 Montreal Road
Atlanta, Georgia 30084
Principal Investigator: Narendra Singh, MD
Phone: 678-679-1065
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Dallas, Texas 75216
Principal Investigator: Subhash Banerjee, MD
Phone: 214-857-1608
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Denver, Colorado 80220
Principal Investigator: Ehrin Armstrong, MD
Phone: 916-762-2666
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Lubbock, Texas 79430
Principal Investigator: Mac Ansari, MD
Phone: 806-743-1501
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Manhasset, New York 11030
Principal Investigator: Mitchell Weinberg, MD
Phone: 516-562-4100
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Minneapolis, Minnesota 55407
Principal Investigator: Nedaa Skeik, MD
Phone: 612-863-6800
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Minneapolis, Minnesota 55417
Principal Investigator: Santiago Garcia, MD
Phone: 612-467-3670
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Oklahoma City, Oklahoma 73104
Principal Investigator: Faisal Latif, MD
Phone: 405-456-3686
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Oklahoma City, OK
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2500 California Plaza
Omaha, Nebraska 68102
(402) 280-2700
Principal Investigator: Syed Mohiuddin, MD
Phone: 402-280-4635
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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Portland, Oregon 97239
Principal Investigator: Matthew Koopmann, MD
Phone: 310-478-3711
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3350 La Jolla Village Drive
San Diego, California 92161
Principal Investigator: Matthew Allison, MD
Phone: 858-552-8585
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Tucson, Arizona 85723
Principal Investigator: Madhan Shanmugasundaram, MD
Phone: 520-792-1450
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