Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT03679858
Status:
UNKNOWN
Last Update Posted:
2018-09-24
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Antisedimentation Rate and Multiplate Exams in Patients on Antiplatelet Therapy and Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'C566800', 'term': 'Platelet Aggregation, Spontaneous'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010979', 'term': 'Platelet Function Tests'}], 'ancestors': [{'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major cerebrovascular event', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebrovascular Disorders', 'Platelet Refractoriness', 'Platelet Aggregation, Spontaneous']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5578190/pdf/ijms-18-01803.pdf', 'label': 'description about Multiple Electrode Aggregometry'}]}, 'descriptionModule': {'briefSummary': 'To search for simple laboratory methods selecting patients with low/non-responsiveness to P2Y12 receptor antagonists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cerebrovascular disorders on antiplatelet therapy as a secundary prevention.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n\nExclusion Criteria:\n\n* Declined informed consent'}, 'identificationModule': {'nctId': 'NCT03679858', 'briefTitle': 'Platelet Antisedimentation Rate and Multiplate Exams in Patients on Antiplatelet Therapy and Controls', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Platelet Antisedimentation Rate and Multiplate ex Vivo Examinations in Cerebrovascular Patients Treated With Antiplatelet Therapy and Healthy Controls', 'orgStudyIdInfo': {'id': 'PTE6735'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Platelet function test in patients', 'description': 'Platelet function test in patients on antiplatelet therapy', 'interventionNames': ['Other: Platelet function test']}, {'label': 'Platelet function test in healthy', 'description': 'Platelet function test in healthy subjects', 'interventionNames': ['Other: Platelet function test']}], 'interventions': [{'name': 'Platelet function test', 'type': 'OTHER', 'description': 'Ex vivo platelet aggregation analysis by Multiplate aggregometer', 'armGroupLabels': ['Platelet function test in healthy', 'Platelet function test in patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7624', 'city': 'Pécs', 'state': 'Baranya', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Erzsebet Ezer, MD', 'role': 'CONTACT', 'email': 'ezererzsebet@yahoo.com', 'phone': '+36302882415'}, {'name': 'Lajos Bogar, MD, DSc', 'role': 'CONTACT', 'email': 'bogar.lajos@pte.hu', 'phone': '+36302889503'}], 'facility': 'University of Pécs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}], 'centralContacts': [{'name': 'Tihamer Molnar, MD, PhD', 'role': 'CONTACT', 'email': 'tihamermolnar@yahoo.com', 'phone': '+36302275814'}], 'overallOfficials': [{'name': 'Tihamer Molnar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pécs Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "Individual participant's aggregometry data will be shared with other researchers."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Tihamér Molnár', 'investigatorAffiliation': 'University of Pecs'}}}}