Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-02-13 @ 4:31 AM
Study NCT ID:
NCT03481257
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2018-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2018-03-28', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'major adverse cardiovascular outcome', 'timeFrame': '1 month', 'description': 'composites of cardiac death, myocardial infarction and target lesion revascularization'}, {'measure': 'BARC bleeding', 'timeFrame': '1 month', 'description': 'ARC definition'}], 'primaryOutcomes': [{'measure': 'Occlusion time', 'timeFrame': '1 month', 'description': 'Global thrombosis test'}], 'secondaryOutcomes': [{'measure': 'Lysis time', 'timeFrame': '1 month', 'description': 'Global thrombosis test'}, {'measure': 'Occlusion time', 'timeFrame': 'Day 2', 'description': 'Global thrombosis test'}, {'measure': 'Lysis time', 'timeFrame': 'Day 2', 'description': 'Global thrombosis test'}, {'measure': 'P2Y12 reaction unit', 'timeFrame': 'Day 2 and 1 month', 'description': 'VerifyNow test'}, {'measure': 'Aspirin reaction unit', 'timeFrame': 'Day 2 and 1 month', 'description': 'VerifyNow test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome', 'Acute Myocardial Infarction', 'Unstable Angina']}, 'descriptionModule': {'briefSummary': 'A total of 50 participants diagnosed with ACS (group A ticagrelor 180mg/d, n=25), group B (clopidogrel 75mg + rivaroxaban 5mg/ d, n=25)) were consecutively enrolled and treated with study drugs on top of aspirin (100mg/d) for 1 month. VerifyNow® and Global thrombosis test were performed at day 2 and 1 month after administration of study drugs. The investigators compared aspirin reaction unit (ARU) and P2Y12 reaction unit (PRU), occlusion time (OT) which reflects shear stress-induced thrombotic activity, and lysis time (LT) which showed endogenous lytic activity between the two strategies at both time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Fifty-six patients from 452 patients who underwent percutaneous coronary intervention (PCI) due to ACS in Seoul National University Bundang Hospital. ( April 2017\\~ January 2018)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who were diagnosed with acute coronary syndrome and underwent percutaneous coronary intervention\n\nExclusion Criteria:\n\n* Patients administered with glycoprotein IIb/IIIa inhibitiors\n* Patients with atrial fibrillation\n* Patients with high risk of bleeding at the physician's discretion\n* Patients with renal impairment (estimated GFR \\<30ml/min)"}, 'identificationModule': {'nctId': 'NCT03481257', 'briefTitle': 'Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Shear Stress-induced Thrombotic and Thrombolytic Effect d Thrombolytic Effect Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel in Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': '06-2017-086'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ticagrelor', 'description': 'ACS patients treated with aspirin (100mg/d) and ticagrelor (90mg bid)'}, {'label': 'Clopidogrel + very low dose rivaroxaban', 'description': 'ACS patients treated with aspirin (100mg/d), clopidogrel(75mg/d) and very low dose rivaroxaban (2.5mg bid)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '463707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Jung-Won Suh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jung-Won Suh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}