Recruiting

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

Sponsor:

North Texas Veterans Healthcare System

Code:

NCT02660866

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo + background APT + SMT

Vorapaxar 2.08 mg/d + background APT + SMT.

Study Details

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).

Conditions

Peripheral Arterial Disease

Study ID

NCT02660866

Start date

Jul, 2016

Status verified date

May, 2018

Completion date

Jul, 2019

Anticipated

Primary completion date

Jul, 2019

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: SMT+APT+Vorapaxar

Interventions

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)

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Ishita Tejani, BDS, MS, MSPH

214-857-3048 ishita.tejani@va.gov

Locations

Southern Arizona VA Health Care System

Recruiting

Tucson, Arizona, United States, 85723

Contacts

Madhan Shanmugasundaram, MD

520-792-1450 madhan.shanmugasundaram@va.gov

Sandra Velasquez

520-792-1450 Sandra.Velasquez@va.gov

Principal Investigator:

Madhan Shanmugasundaram, MD

San Diego VA Medical center

Recruiting

San Diego, California, United States, 92161

Contacts

Matthew Allison, MD

858-552-8585 mallison@ucsd.edu

Amelia Parnell

amelia.parnell@va.gov

Principal Investigator:

Matthew Allison, MD

VA Eastern Colorado Healthcare System

Recruiting

Denver, Colorado, United States, 80220

Contacts

Ehrin Armstrong, MD

916-762-2666 ehrin.armstrong@va.gov

Caitlin Hutchinson

303-399-8020 Caitlin.hutchinson@va.gov

Principal Investigator:

Ehrin Armstrong, MD

Atlanta Heart Specialists

Recruiting

Atlanta, Georgia, United States, 30084

Contacts

Narendra Singh, MD

678-679-1065 disingh@ahsmed.com

Kati Raynes

kati@ahsmed.com

Principal Investigator:

Narendra Singh, MD

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Nedaa Skeik, MD

612-863-6800 nedaa.skeik@allina.com

Laura Onstot

612-863-6120 laura.onstot@allina.com

Principal Investigator:

Nedaa Skeik, MD

Minneapolis VA Medical center

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Santiago Garcia, MD

612-467-3670 santiago.garcia@va.gov

Rebekah Hermann, RN

612-467-3668 rebekah.herrmann@va.gov

Principal Investigator:

Santiago Garcia, MD

Creighton University

Recruiting

Omaha, Nebraska, United States, 68131

Contacts

Syed Mohiuddin, MD

402-280-4635 smm@creighton.edu

Brittni Gochnauer

402-280-4448 brittnigochnauer@creighton.edu

Principal Investigator:

Syed Mohiuddin, MD

Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Contacts

Mitchell Weinberg, MD

516-562-4100 mweinberg@northwell.edu

Vidya Seeratan

516-562-2653 vseeratan@northwell.edu

Principal Investigator:

Mitchell Weinberg, MD

OKlahoma VA Medical Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Faisal Latif, MD

405-456-3686 faisal.latif@va.gov

Cheryl Adams, RN

405-456-1775 cheryl.adams@va.gov

Principal Investigator:

Faisal Latif, MD

VA Portland Health Care System

Recruiting

Portland, Oregon, United States, 97239

Contacts

Matthew Koopmann, MD

310-478-3711 matthew.koopmann@va.gov

Joy Usih

503-220-8262 joy.usih@va.gov

Principal Investigator:

Matthew Koopmann, MD

VA North Texas Health Care System

Recruiting

Dallas, Texas, United States, 75216

Contacts

Subhash Banerjee, MD

214-857-1608 subhash.banerjee@utsouthwestern.edu

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

Contacts

Mac Ansari, MD

806-743-1501 mac.ansari@ttuhsc.edu

Ronnie Orozco, MS

806-743-6900 ronnie.orozco@ttuhsc.edu

Principal Investigator:

Mac Ansari, MD

More Information

Sponsor

North Texas Veterans Healthcare System

Last update posted

May 29, 2018

Last verified

May, 2018

Keywords

intermittent claudication
randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Texas Veterans Healthcare System on 2018-05-29.