Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-30 @ 5:22 AM
Study NCT ID:
NCT01839968
Status:
COMPLETED
Last Update Posted:
2014-08-19
First Post:
2013-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2013-04-22', 'studyFirstSubmitQcDate': '2013-04-24', 'lastUpdatePostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet reactivity assessed by light transmittance aggregometry (LTA) after ex-vivo normal platelet addition', 'timeFrame': 'within the first 6-24 hours after antiplatelet drug loading dose'}]}, 'conditionsModule': {'conditions': ['Acquired Platelet Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute coronary syndrome who received a loading dose of prasugrel within 6 and 24h.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute coronary syndrome\n* Prasugrel loading dose 6-24h before inclusion\n\nExclusion Criteria:\n\n* Clopidogrel loading dose\n* GPIIbIIIa use within 10 days before inclusion\n* Known congenital thrombopathy and/or congenital coagulation defect'}, 'identificationModule': {'nctId': 'NCT01839968', 'briefTitle': 'Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'orgStudyIdInfo': {'id': '11-117'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study patients', 'description': 'Acute coronary syndrome patients with a recent loading dose of prasugrel (6-24h)', 'interventionNames': ['Other: Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma']}], 'interventions': [{'name': 'Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma', 'type': 'OTHER', 'armGroupLabels': ['Study patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'University Hospital of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Fanny Bonhomme', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}