Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-02-18 @ 1:39 AM
Study NCT ID:
NCT01001260
Status:
TERMINATED
Last Update Posted:
2019-06-11
First Post:
2009-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PGD2 Formation in Vascular Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D057772', 'term': 'Vascular System Injuries'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C098312', 'term': 'nitroxy-butyl-acetylsalicylic acid'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Specimens:\n\n 3 urine collections will be obtained (Prior to PTCA, During PTCA and Post PTCA)\n* Genetic Testing:\n\nanalysis of the association of SNPs in Cox genes with variability in selectively or in the PGEs genes in quantitative biosynthesis of PGD2 and related compounds.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'whyStopped': 'Unable to find subjects that met inclusion/exclusion criteria.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-10', 'studyFirstSubmitDate': '2009-10-14', 'studyFirstSubmitQcDate': '2009-10-22', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The increment of PGD2 synthesis reflected by an novel biomarker of urinary PGD2 metabolite.', 'timeFrame': '18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection.'}], 'secondaryOutcomes': [{'measure': 'Whether aspirin could blunt the increment of PGD2 if there is.', 'timeFrame': '18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostaglandins', 'vascular injury'], 'conditions': ['Coronary Artery Disease', 'Acute Coronary Syndrome', 'Stable Angina']}, 'descriptionModule': {'briefSummary': 'To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty (PTCA) procedure.', 'detailedDescription': 'A) To determine whether biosynthesis of PGD2 is altered in response to vascular injury in humans\n\nB) Patients will be grouped base on their aspirin using status. Three groups of no aspirin but an alternative anti-platelet medicine, low dose (81 mg) aspirin, high dose 325 mg aspirin will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled to have PTCA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with existing CAD admitted for elective PTCA:\n\n 1. Treated with any dose of aspirin daily for at least 5 days, with special interest in those treated with 81 mg aspirin daily or\n 2. Treated with an alternative antiplatelet therapy, such as clopidogrel, due to aspirin hypersensitivity or PMDs preference or\n 3. No aspirin therapy at all\n* Patients presenting to the ER with Acute Coronary Syndrome(ACS)who will have a PTCA\n* Patients with stable angina or positive stress tests scheduled for a cardiac catheterization\n\nExclusion Criteria:\n\n* History of unstable diabetes (hgb A1c\\>8 or FBS\\> 200)\n* Uncontrolled hypertension (SBP \\> 180, DBP \\>100)\n* History of an acute confounding disease as judged on clinical screen that according to the investigator may interfere with interpretation of the study results, or compromise the safety of a potential subject.\n* Patients who have taken NSAIDS or COX-2 inhibitors other than aspirin, for at least 10 days prior to PTCA'}, 'identificationModule': {'nctId': 'NCT01001260', 'acronym': 'PGD2', 'briefTitle': 'PGD2 Formation in Vascular Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Biosynthesis of PGD2 in Vascular Injury', 'orgStudyIdInfo': {'id': '804975'}, 'secondaryIdInfos': [{'id': 'American Heart Association'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Aspirin Treatment', 'interventionNames': ['Drug: No ASA']}, {'label': '81 mg Aspirin Treatment', 'interventionNames': ['Drug: Low dose ASA']}, {'label': '325 mg Aspirin', 'interventionNames': ['Drug: 325 mg ASA']}], 'interventions': [{'name': 'No ASA', 'type': 'DRUG', 'description': 'Alternative antiplatelet therapy instead of aspirin', 'armGroupLabels': ['No Aspirin Treatment']}, {'name': 'Low dose ASA', 'type': 'DRUG', 'description': 'Low dose aspirin (81mg) prior to PTCA', 'armGroupLabels': ['81 mg Aspirin Treatment']}, {'name': '325 mg ASA', 'type': 'DRUG', 'description': 'high dose of aspirin prior to PTCA', 'armGroupLabels': ['325 mg Aspirin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Garret FitzGerald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Wenliang Song, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}