Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)
NCT ID: NCT02660866
Last Updated: 2018-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2016-07-31
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Placebo + background APT + SMT
Placebo drug therapy combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
Vorapaxar 2.08 mg/d + background APT + SMT.
Vorapaxar 2.08 mg/d combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
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
Placebo + background APT + SMT
Placebo drug therapy combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
Vorapaxar 2.08 mg/d + background APT + SMT.
Vorapaxar 2.08 mg/d combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
Interventions
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Placebo + background APT + SMT
Placebo drug therapy combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
Vorapaxar 2.08 mg/d + background APT + SMT.
Vorapaxar 2.08 mg/d combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
90 Years
ALL
No
Sponsors
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North Texas Veterans Healthcare System
FED
Responsible Party
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Subhash Banerjee
Chief, Cardiology Division
Locations
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Southern Arizona VA Health Care System
Tucson, Arizona, United States
San Diego VA Medical center
San Diego, California, United States
VA Eastern Colorado Healthcare System
Denver, Colorado, United States
Atlanta Heart Specialists
Atlanta, Georgia, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Minneapolis VA Medical center
Minneapolis, Minnesota, United States
Creighton University
Omaha, Nebraska, 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
VA North Texas Health Care System
Dallas, Texas, United States
Texas Tech University Health Science Center
Lubbock, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Hirsch AT, Hiatt WR; PARTNERS Steering Committee. PAD awareness, risk, and treatment: new resources for survival--the USA PARTNERS program. Vasc Med. 2001;6(3 Suppl):9-12. doi: 10.1177/1358836X0100600i103.
McBurney CR, Eagle KA, Kline-Rogers EM, Cooper JV, Mani OC, Smith DE, Erickson SR. Health-related quality of life in patients 7 months after a myocardial infarction: factors affecting the Short Form-12. Pharmacotherapy. 2002 Dec;22(12):1616-22. doi: 10.1592/phco.22.17.1616.34121.
Tsai S, Liu Y, Alaiti MA, Gutierrez JA, Brilakis ES, Banerjee S. No benefit of vorapaxar on walking performance in patients with intermittent claudication. Vasc Med. 2022 Feb;27(1):33-38. doi: 10.1177/1358863X211042082. Epub 2021 Oct 5.
Other Identifiers
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xlpadtrace
Identifier Type: -
Identifier Source: org_study_id
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