Peripheral Arterial DiseasePhase 4XLPADTRACENCT02660866
Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)
A Phase 4 study testing Vorapaxar 2.08 mg/d + background APT + SMT. in people with Peripheral Arterial Disease, run by North Texas Veterans Healthcare System at 12 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Vorapaxar 2.08 mg/d + background APT + SMT.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 12 sitesUnited States
- Study dates
- Jul 2016to Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Atlanta Heart Specialists
Atlanta, Georgia, 30084
Narendra Singh, MD, 678-679-1065, disingh@ahsmed.com
Kati Raynes, kati@ahsmed.com
- Recruiting
VA North Texas Health Care System
Dallas, Texas, 75216
Subhash Banerjee, MD, 214-857-1608, subhash.banerjee@utsouthwestern.edu
Ishita Tejani, BDS, MS, MSPH, 214-857-3048, ishita.tejani@va.gov
- Recruiting
VA Eastern Colorado Healthcare System
Denver, Colorado, 80220
Ehrin Armstrong, MD, 916-762-2666, ehrin.armstrong@va.gov
Caitlin Hutchinson, 303-399-8020 ext. 4019, Caitlin.hutchinson@va.gov
- Recruiting
Texas Tech University Health Science Center
Lubbock, Texas, 79430
Mac Ansari, MD, 806-743-1501, mac.ansari@ttuhsc.edu
Ronnie Orozco, MS, 806-743-6900, ronnie.orozco@ttuhsc.edu
- Recruiting
Northwell Health
Manhasset, New York, 11030
Mitchell Weinberg, MD, 516-562-4100, mweinberg@northwell.edu
Vidya Seeratan, 516-562-2653, vseeratan@northwell.edu
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Nedaa Skeik, MD, 612-863-6800, nedaa.skeik@allina.com
Laura Onstot, 612-863-6120, laura.onstot@allina.com
- Recruiting
Minneapolis VA Medical center
Minneapolis, Minnesota, 55417
Santiago Garcia, MD, 612-467-3670, santiago.garcia@va.gov
Rebekah Hermann, RN, 612-467-3668, rebekah.herrmann@va.gov
- Recruiting
OKlahoma VA Medical Center
Oklahoma City, Oklahoma, 73104
Faisal Latif, MD, 405-456-3686, faisal.latif@va.gov
Cheryl Adams, RN, 405-456-1775, cheryl.adams@va.gov
- Recruiting
Creighton University
Omaha, Nebraska, 68131
Syed Mohiuddin, MD, 402-280-4635, smm@creighton.edu
Brittni Gochnauer, 402-280-4448, brittnigochnauer@creighton.edu
- Recruiting
VA Portland Health Care System
Portland, Oregon, 97239
Matthew Koopmann, MD, 310-478-3711, matthew.koopmann@va.gov
Joy Usih, 503-220-8262 ext. 58388, joy.usih@va.gov
- Recruiting
San Diego VA Medical center
San Diego, California, 92161
Matthew Allison, MD, 858-552-8585 ext. 3289, mallison@ucsd.edu
Amelia Parnell, amelia.parnell@va.gov
- Recruiting
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Madhan Shanmugasundaram, MD, 520-792-1450 ext. 4624, madhan.shanmugasundaram@va.gov
Sandra Velasquez, 520-792-1450 ext. 5691, Sandra.Velasquez@va.gov
About this study
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).
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Placebo + background APT + SMT, Vorapaxar 2.08 mg/d + background APT + SMT.
- Keywords
- intermittent claudication, randomized controlled trial
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo + background APT + SMTDrug
Placebo drug therapy combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
Vorapaxar 2.08 mg/d + background APT + SMT.Drug
Vorapaxar 2.08 mg/d combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
| Study group | Role | What they receive |
|---|---|---|
| SMT+APT+Placebo | Placebo comparator | 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. Receives: Drug: Placebo + background APT + SMT; Drug: Vorapaxar 2.08 mg/d + background APT + SMT. |
| SMT+APT+Vorapaxar | Active comparator | 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 Receives: Drug: Placebo + background APT + SMT; Drug: Vorapaxar 2.08 mg/d + background APT + SMT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Subhash Banerjee, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660866
- Sponsor's protocol ID
- xlpadtrace
- Acronym
- XLPADTRACE
- Status last verified
- May 2018
- First submitted
- 30 Dec 2015
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Deidentified study results will be shared through clinicaltrials.gov and other publically available portals.
Publications
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.
PubMed 11789964McBurney 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.
PubMed 12495171Tsai 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.
PubMed 34609939
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)
- ClinicalTrials.gov ID
- NCT02660866
- Acronym / sponsor ID
- XLPADTRACE / xlpadtrace
- Conditions
- Peripheral Arterial Disease
- Keywords
- intermittent claudication, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Jul 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMT+APT+Placebo | Placebo comparator | Drug: Placebo + background APT + SMT, Drug: 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 | Active comparator | Drug: Placebo + background APT + SMT, Drug: 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 |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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]
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo + background APT + SMTPlacebo drug therapy combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy) | Drug | SMT+APT+Placebo, SMT+APT+Vorapaxar |
| Vorapaxar 2.08 mg/d + background APT + SMT.Vorapaxar 2.08 mg/d combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy) | Drug | SMT+APT+Placebo, SMT+APT+Vorapaxar |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Results publication: PubMed 11789964Hirsch 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.
- Results publication: PubMed 12495171McBurney 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.
- Derived from this study: PubMed 34609939Tsai 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.
- Individual participant dataSharing planned: Yes. Deidentified study results will be shared through clinicaltrials.gov and other publically available portals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vorapaxar 2.08 mg/d + background APT + SMT. in people with Peripheral Arterial Disease, run by North Texas Veterans Healthcare System at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ishita Tejani, BDS, MS, MSPH (214-857-3048, ishita.tejani@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660866, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.