Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-22 @ 5:24 PM
Study NCT ID:
NCT02660866
Status:
UNKNOWN
Last Update Posted:
2018-05-29
First Post:
2015-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-12-15', 'releaseDate': '2021-11-18'}], 'estimatedResultsFirstSubmitDate': '2021-11-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530299', 'term': 'vorapaxar'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2015-12-30', 'studyFirstSubmitQcDate': '2016-01-19', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '6 months', 'description': '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.\n\nChange 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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intermittent claudication', 'randomized controlled trial'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '11789964', 'type': 'RESULT', 'citation': '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': '12495171', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '34609939', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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)\n\nStudy 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\n\nSecondary endpoints\n\n* 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.\n* 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.\n* 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\n\nTertiary endpoints\n\n* 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.\n* 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.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Pre-screening criteria\n\n* Laboratory values available ≤ 1 year of the date of screening: hemoglobin ≥9g, platelet count \\>50,000 mm3 or \\<600,000 mm3\n* No history of stroke or transient ischemic attack (TIA)\n* No allergy to aspirin\n* ≥40 years of age\n* 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:\n\n 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\n* Documented IC Rutherford/Becker (RC) category ≥2\n* 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\n* No planned surgical or endovascular procedures other than for the treatment of IC for the expected duration of the study\n* No warfarin or other chronic oral anticoagulant use within the last 14 days\n* No use of ticagrelor, clopidogrel, prasugrel or ticlopidine within last 7 days\n* 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\n* No use of cilostazol and/or pentoxyphilline within last 7 days\n* Severe psychiatric or behavioral illness that in the judgement of the investigator precludes study participation\n* No history of major or minor amputation\n* Severe heart, vascular and lung disease in the discretion of the investigator that precludes study participation.\n* Ability to walk for at least 15 min/day, at least 3 days/week, at ≥20 steps/min\n\nInclusion criteria\n\n* Treadmill PWT= 2-10 min on Gardner protocol\n* Estimated survival ≥1 year in the judgment of the site investigator\n* 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).\n* 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\\]\n\nExclusion Criteria:\n\n* MI or percutaneous coronary intervention (PCI) with DES within the past 11 months\n* Positive pregnancy test\n* Planned surgical or endovascular procedures other than for the treatment of IC\n* Warfarin or other chronic oral anticoagulant use within 14 days\n* Use of Ticagrelor, Clopidogrel, Prasugrel or Ticlopidine within 7 days\n* 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\n* Use of cilostazol and/or pentoxyphilline within 7 days'}, 'identificationModule': {'nctId': 'NCT02660866', 'acronym': 'XLPADTRACE', 'briefTitle': 'Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)', 'organization': {'class': 'FED', 'fullName': 'North Texas Veterans Healthcare System'}, 'officialTitle': 'Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)', 'orgStudyIdInfo': {'id': 'xlpadtrace'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'SMT+APT+Placebo', 'description': '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\n\nBackground 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.', 'interventionNames': ['Drug: Placebo + background APT + SMT', 'Drug: Vorapaxar 2.08 mg/d + background APT + SMT.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SMT+APT+Vorapaxar', 'description': '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\n\nBackground 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.\n\nVorapaxar: Vorapaxar 2.08mg/day', 'interventionNames': ['Drug: Placebo + background APT + SMT', 'Drug: Vorapaxar 2.08 mg/d + background APT + SMT.']}], 'interventions': [{'name': 'Placebo + background APT + SMT', 'type': 'DRUG', 'description': 'Placebo drug therapy combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)', 'armGroupLabels': ['SMT+APT+Placebo', 'SMT+APT+Vorapaxar']}, {'name': 'Vorapaxar 2.08 mg/d + background APT + SMT.', 'type': 'DRUG', 'description': 'Vorapaxar 2.08 mg/d combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)', 'armGroupLabels': ['SMT+APT+Placebo', 'SMT+APT+Vorapaxar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madhan Shanmugasundaram, MD', 'role': 'CONTACT', 'email': 'madhan.shanmugasundaram@va.gov', 'phone': '520-792-1450', 'phoneExt': '4624'}, {'name': 'Sandra Velasquez', 'role': 'CONTACT', 'email': 'Sandra.Velasquez@va.gov', 'phone': '520-792-1450', 'phoneExt': '5691'}, {'name': 'Madhan Shanmugasundaram, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Arizona VA Health Care System', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Allison, MD', 'role': 'CONTACT', 'email': 'mallison@ucsd.edu', 'phone': '858-552-8585', 'phoneExt': '3289'}, {'name': 'Amelia Parnell', 'role': 'CONTACT', 'email': 'amelia.parnell@va.gov'}, {'name': 'Matthew Allison, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Diego VA Medical center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ehrin Armstrong, MD', 'role': 'CONTACT', 'email': 'ehrin.armstrong@va.gov', 'phone': '916-762-2666'}, {'name': 'Caitlin Hutchinson', 'role': 'CONTACT', 'email': 'Caitlin.hutchinson@va.gov', 'phone': '303-399-8020', 'phoneExt': '4019'}, {'name': 'Ehrin Armstrong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA Eastern Colorado Healthcare System', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30084', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Narendra Singh, MD', 'role': 'CONTACT', 'email': 'disingh@ahsmed.com', 'phone': '678-679-1065'}, {'name': 'Kati Raynes', 'role': 'CONTACT', 'email': 'kati@ahsmed.com'}, {'name': 'Narendra Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atlanta Heart Specialists', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nedaa Skeik, MD', 'role': 'CONTACT', 'email': 'nedaa.skeik@allina.com', 'phone': '612-863-6800'}, {'name': 'Laura Onstot', 'role': 'CONTACT', 'email': 'laura.onstot@allina.com', 'phone': '612-863-6120'}, {'name': 'Nedaa Skeik, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Minneapolis Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Santiago Garcia, MD', 'role': 'CONTACT', 'email': 'santiago.garcia@va.gov', 'phone': '612-467-3670'}, {'name': 'Rebekah Hermann, RN', 'role': 'CONTACT', 'email': 'rebekah.herrmann@va.gov', 'phone': '612-467-3668'}, {'name': 'Santiago Garcia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Minneapolis VA Medical center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Syed Mohiuddin, MD', 'role': 'CONTACT', 'email': 'smm@creighton.edu', 'phone': '402-280-4635'}, {'name': 'Brittni Gochnauer', 'role': 'CONTACT', 'email': 'brittnigochnauer@creighton.edu', 'phone': '402-280-4448'}, {'name': 'Syed Mohiuddin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitchell Weinberg, MD', 'role': 'CONTACT', 'email': 'mweinberg@northwell.edu', 'phone': '516-562-4100'}, {'name': 'Vidya Seeratan', 'role': 'CONTACT', 'email': 'vseeratan@northwell.edu', 'phone': '516-562-2653'}, {'name': 'Mitchell Weinberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Faisal Latif, MD', 'role': 'CONTACT', 'email': 'faisal.latif@va.gov', 'phone': '405-456-3686'}, {'name': 'Cheryl Adams, RN', 'role': 'CONTACT', 'email': 'cheryl.adams@va.gov', 'phone': '405-456-1775'}, {'name': 'Faisal Latif, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OKlahoma VA Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Koopmann, MD', 'role': 'CONTACT', 'email': 'matthew.koopmann@va.gov', 'phone': '310-478-3711'}, {'name': 'Joy Usih', 'role': 'CONTACT', 'email': 'joy.usih@va.gov', 'phone': '503-220-8262', 'phoneExt': '58388'}, {'name': 'Matthew Koopmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA Portland Health Care System', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Subhash Banerjee, MD', 'role': 'CONTACT', 'email': 'subhash.banerjee@utsouthwestern.edu', 'phone': '214-857-1608'}, {'name': 'Ishita Tejani, BDS, MS, MSPH', 'role': 'CONTACT', 'email': 'ishita.tejani@va.gov', 'phone': '214-857-3048'}, {'name': 'Subhash Banerjee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA North Texas Health Care System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mac Ansari, MD', 'role': 'CONTACT', 'email': 'mac.ansari@ttuhsc.edu', 'phone': '806-743-1501'}, {'name': 'Ronnie Orozco, MS', 'role': 'CONTACT', 'email': 'ronnie.orozco@ttuhsc.edu', 'phone': '806-743-6900'}, {'name': 'Mac Ansari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Tech University Health Science Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'centralContacts': [{'name': 'Ishita Tejani, BDS, MS, MSPH', 'role': 'CONTACT', 'email': 'ishita.tejani@va.gov', 'phone': '214-857-3048'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Deidentified study results will be shared through clinicaltrials.gov and other publically available portals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Texas Veterans Healthcare System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Cardiology Division', 'investigatorFullName': 'Subhash Banerjee', 'investigatorAffiliation': 'North Texas Veterans Healthcare System'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-11-18', 'type': 'RELEASE'}, {'date': '2021-12-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Subhash Banerjee, Chief, Cardiology Division, North Texas Veterans Healthcare System'}}}}