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

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ClinicalTrials.gov Identifier: NCT02660866
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Subhash Banerjee, North Texas Veterans Healthcare System

Brief 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).

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: Placebo + background APT + SMT Drug: Vorapaxar 2.08 mg/d + background APT + SMT. Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: SMT+APT+Placebo

Standard Medical Therapy (SMT): Presence of any two of the listed classes of agents [angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), statin therapy and beta-blocker drugs] + ability to perform at least 15 min of home walking a day, at least 3 times/week, at ≥20 steps/min

Background Antiplatelet Therapy (APT) :At least one aspirin dose within 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 within 5 days prior to randomization at 81 mg dose in patients on chronic (>5 days of prior use) aspirin therapy.

Drug: Placebo + background APT + SMT
Placebo drug therapy combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)

Drug: Vorapaxar 2.08 mg/d + background APT + SMT.
Vorapaxar 2.08 mg/d combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)

Active Comparator: SMT+APT+Vorapaxar

Standard Medical Therapy (SMT): Presence of any two of the listed classes of agents [angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), statin therapy and beta-blocker drugs] + ability to perform at least 15 min of home walking a day, at least 3 times/week, at ≥20 steps/min

Background Antiplatelet Therapy (APT) :At least one aspirin dose within 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 within 5 days prior to randomization at 81 mg dose in patients on chronic (>5 days of prior use) aspirin therapy.

Vorapaxar: Vorapaxar 2.08mg/day

Drug: Placebo + background APT + SMT
Placebo drug therapy combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)

Drug: Vorapaxar 2.08 mg/d + background APT + SMT.
Vorapaxar 2.08 mg/d combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)




Primary Outcome Measures :
  1. 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 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660866


Contacts
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Contact: Ishita Tejani, BDS, MS, MSPH 214-857-3048 ishita.tejani@va.gov

Locations
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United States, Arizona
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact: Madhan Shanmugasundaram, MD    520-792-1450 ext 4624    madhan.shanmugasundaram@va.gov   
Contact: Sandra Velasquez    520-792-1450 ext 5691    Sandra.Velasquez@va.gov   
Principal Investigator: Madhan Shanmugasundaram, MD         
United States, California
San Diego VA Medical center Recruiting
San Diego, California, United States, 92161
Contact: Matthew Allison, MD    858-552-8585 ext 3289    mallison@ucsd.edu   
Contact: Amelia Parnell       amelia.parnell@va.gov   
Principal Investigator: Matthew Allison, MD         
United States, Colorado
VA Eastern Colorado Healthcare System Recruiting
Denver, Colorado, United States, 80220
Contact: Ehrin Armstrong, MD    916-762-2666    ehrin.armstrong@va.gov   
Contact: Caitlin Hutchinson    303-399-8020 ext 4019    Caitlin.hutchinson@va.gov   
Principal Investigator: Ehrin Armstrong, MD         
United States, Georgia
Atlanta Heart Specialists Recruiting
Atlanta, Georgia, United States, 30084
Contact: Narendra Singh, MD    678-679-1065    disingh@ahsmed.com   
Contact: Kati Raynes       kati@ahsmed.com   
Principal Investigator: Narendra Singh, MD         
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Nedaa Skeik, MD    612-863-6800    nedaa.skeik@allina.com   
Contact: Laura Onstot    612-863-6120    laura.onstot@allina.com   
Principal Investigator: Nedaa Skeik, MD         
Minneapolis VA Medical center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Santiago Garcia, MD    612-467-3670    santiago.garcia@va.gov   
Contact: Rebekah Hermann, RN    612-467-3668    rebekah.herrmann@va.gov   
Principal Investigator: Santiago Garcia, MD         
United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68131
Contact: Syed Mohiuddin, MD    402-280-4635    smm@creighton.edu   
Contact: Brittni Gochnauer    402-280-4448    brittnigochnauer@creighton.edu   
Principal Investigator: Syed Mohiuddin, MD         
United States, New York
Northwell Health Recruiting
Manhasset, New York, United States, 11030
Contact: Mitchell Weinberg, MD    516-562-4100    mweinberg@northwell.edu   
Contact: Vidya Seeratan    516-562-2653    vseeratan@northwell.edu   
Principal Investigator: Mitchell Weinberg, MD         
United States, Oklahoma
OKlahoma VA Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Faisal Latif, MD    405-456-3686    faisal.latif@va.gov   
Contact: Cheryl Adams, RN    405-456-1775    cheryl.adams@va.gov   
Principal Investigator: Faisal Latif, MD         
United States, Oregon
VA Portland Health Care System Recruiting
Portland, Oregon, United States, 97239
Contact: Matthew Koopmann, MD    310-478-3711    matthew.koopmann@va.gov   
Contact: Joy Usih    503-220-8262 ext 58388    joy.usih@va.gov   
Principal Investigator: Matthew Koopmann, MD         
United States, Texas
VA North Texas Health Care System Recruiting
Dallas, Texas, United States, 75216
Contact: Subhash Banerjee, MD    214-857-1608    subhash.banerjee@utsouthwestern.edu   
Contact: Ishita Tejani, BDS, MS, MSPH    214-857-3048    ishita.tejani@va.gov   
Principal Investigator: Subhash Banerjee, MD         
Texas Tech University Health Science Center Recruiting
Lubbock, Texas, United States, 79430
Contact: Mac Ansari, MD    806-743-1501    mac.ansari@ttuhsc.edu   
Contact: Ronnie Orozco, MS    806-743-6900    ronnie.orozco@ttuhsc.edu   
Principal Investigator: Mac Ansari, MD         
Sponsors and Collaborators
North Texas Veterans Healthcare System

Publications of Results:
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Responsible Party: Subhash Banerjee, Chief, Cardiology Division, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT02660866     History of Changes
Other Study ID Numbers: xlpadtrace
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified study results will be shared through clinicaltrials.gov and other publically available portals.

Keywords provided by Subhash Banerjee, North Texas Veterans Healthcare System:
intermittent claudication
randomized controlled trial

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Aspirin
Thrombin
Vorapaxar
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Antipyretics
Hemostatics