Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT01935193
Status:
UNKNOWN
Last Update Posted:
2013-09-05
First Post:
2013-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aspirin Resistance Reversibility in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-01-16', 'releaseDate': '2015-01-13'}], 'estimatedResultsFirstSubmitDate': '2015-01-13'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C010395', 'term': 'acetylsalicylic acid lysinate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-08-30', 'studyFirstSubmitDate': '2013-08-28', 'studyFirstSubmitQcDate': '2013-08-30', 'lastUpdatePostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'platelets aggregation assessed by two tests (PFA100 and VerifyNow)', 'timeFrame': '24 hours', 'description': 'diabetic patients found aspirin resistant receive and infusion of 288 mg of lysine acetylsalicylate and they are tested again 24 h after the infusion to investigate if aspirin resistance have been reversed.'}], 'secondaryOutcomes': [{'measure': 'stability of aggregation state after the reversion of aspirin resistance using oral formulation of lysine acetylsalicylate', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['platelets aggregation', 'asa resistance'], 'conditions': ['Aspirin Resistance']}, 'descriptionModule': {'briefSummary': 'The aim of the study is assessing the prevalence of aspirin resistance in a cohort of diabetic patients. Those found resistant has been undergone pharmacological tests using different drug formulations to investigate the reversibility of aspirin resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabete mellitus type 2\n* asa since 30 days at least\n* plts \\>150000 and \\<450000\n\nExclusion Criteria:\n\n* recent ACS (within 30 days)\n* anticoagulant therapy\n* haemorragic diathesis'}, 'identificationModule': {'nctId': 'NCT01935193', 'acronym': 'ARRDM', 'briefTitle': 'Aspirin Resistance Reversibility in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera San Giovanni Battista'}, 'officialTitle': 'Impact of Different Pharmacological Formulations on Aspirin Resistance Reversibility in Diabetics Patients', 'orgStudyIdInfo': {'id': 'ASAR160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'asa resistant', 'description': 'asa resistant patients receive endovenous infusion of lysine acetylsalicylate 288 mg and if asa resistance has been reversed they have been prescribed oral soluble salt of lysine acetylsalicylate.', 'interventionNames': ['Drug: lysine acetylsalicylate']}], 'interventions': [{'name': 'lysine acetylsalicylate', 'type': 'DRUG', 'otherNames': ['Flectadol', 'Cardirene'], 'armGroupLabels': ['asa resistant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marta Bisi, MD', 'role': 'CONTACT', 'email': 'martadoro@hotmail.com', 'phone': '+393476985414'}], 'facility': 'San Giovanni Battista Hospital', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'centralContacts': [{'name': 'Marta Bisi, MD', 'role': 'CONTACT', 'email': 'martadoro@hotmail.com', 'phone': '+393476985414'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera San Giovanni Battista', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Marta Bisi', 'investigatorAffiliation': 'Azienda Ospedaliera San Giovanni Battista'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-01-13', 'type': 'RELEASE'}, {'date': '2015-01-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Marta Bisi, MD, Azienda Ospedaliera San Giovanni Battista'}}}}