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

May 24, 2018 updated by: Subhash Banerjee, North Texas Veterans Healthcare System
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Recruiting
        • Southern Arizona VA Health Care System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Madhan Shanmugasundaram, MD
    • California
      • San Diego, California, United States, 92161
        • Recruiting
        • San Diego VA Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthew Allison, MD
    • Colorado
      • Denver, Colorado, United States, 80220
    • Georgia
      • Atlanta, Georgia, United States, 30084
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Recruiting
        • Minneapolis VA Medical Center
        • Principal Investigator:
          • Santiago Garcia, MD
        • Contact:
        • Contact:
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nedaa Skeik, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Recruiting
        • Creighton University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Syed Mohiuddin, MD
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mitchell Weinberg, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Oklahoma VA Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Faisal Latif, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • VA Portland Health Care System
        • Contact:
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75216
        • Recruiting
        • VA North Texas Health Care System
        • Contact:
        • Principal Investigator:
          • Subhash Banerjee, MD
        • Contact:
      • Lubbock, Texas, United States, 79430
        • Recruiting
        • Texas Tech University Health Science Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mac Ansari, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Veterans Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xlpadtrace

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified study results will be shared through clinicaltrials.gov and other publically available portals.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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