Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)
- Conditions
- Peripheral Arterial Disease
- Interventions
- Drug: Placebo + background APT + SMT
- Registration Number
- NCT02660866
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SMT+APT+Placebo Vorapaxar 2.08 mg/d + background APT + SMT. 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. SMT+APT+Vorapaxar Vorapaxar 2.08 mg/d + background APT + SMT. 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 SMT+APT+Placebo Placebo + background APT + SMT 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. SMT+APT+Vorapaxar Placebo + background APT + SMT 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
- Primary Outcome Measures
Name Time Method 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 6 months
- Secondary Outcome Measures
Name Time Method 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. 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.
Trial Locations
- Locations (12)
Atlanta Heart Specialists
🇺🇸Atlanta, Georgia, United States
San Diego VA Medical center
🇺🇸San Diego, California, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Northwell Health
🇺🇸Manhasset, New York, United States
OKlahoma VA Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
VA Portland Health Care System
🇺🇸Portland, Oregon, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
VA Eastern Colorado Healthcare System
🇺🇸Denver, Colorado, United States
Creighton University
🇺🇸Omaha, Nebraska, United States
Minneapolis VA Medical center
🇺🇸Minneapolis, Minnesota, United States
VA North Texas Health Care System
🇺🇸Dallas, Texas, United States