Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)
XLPADTRACE
1 other identifier
interventional
200
1 country
12
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2016
Typical duration for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2015
CompletedFirst Posted
Study publicly available on registry
January 21, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedMay 29, 2018
May 1, 2018
3 years
December 30, 2015
May 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
6 months
Secondary Outcomes (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.
6 months
Study Arms (2)
SMT+APT+Placebo
PLACEBO COMPARATORStandard 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
ACTIVE COMPARATORStandard 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
Interventions
Placebo drug therapy combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
Vorapaxar 2.08 mg/d combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
Eligibility Criteria
You may qualify if:
- 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 \[angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), lipid lowering therapy, aspirin and beta-blocker drugs\]
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
San Diego VA Medical center
San Diego, California, 92161, United States
VA Eastern Colorado Healthcare System
Denver, Colorado, 80220, United States
Atlanta Heart Specialists
Atlanta, Georgia, 30084, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Minneapolis VA Medical center
Minneapolis, Minnesota, 55417, United States
Creighton University
Omaha, Nebraska, 68131, United States
Northwell Health
Manhasset, New York, 11030, United States
OKlahoma VA Medical Center
Oklahoma City, Oklahoma, 73104, United States
VA Portland Health Care System
Portland, Oregon, 97239, United States
VA North Texas Health Care System
Dallas, Texas, 75216, United States
Texas Tech University Health Science Center
Lubbock, Texas, 79430, United States
Related Publications (3)
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.
PMID: 11789964RESULTMcBurney 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.
PMID: 12495171RESULTTsai 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.
PMID: 34609939DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Cardiology Division
Study Record Dates
First Submitted
December 30, 2015
First Posted
January 21, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
May 29, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will share
Deidentified study results will be shared through clinicaltrials.gov and other publically available portals.