Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02914795
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Platelet Function in Resuscitated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dirk.von-lewinski@medunigraz.at', 'phone': '+43 316 385', 'title': 'Assoc. Prof. Dr. Dirk von Lewinski', 'phoneExt': '80684', 'organization': 'Medical University of Grazt'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '7 days', 'eventGroups': [{'id': 'EG000', 'title': 'Resuscitated MI', 'description': 'Death within the Observation period of 7 days; n=3', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non Resuscitated MI', 'description': 'Death within the Observation period of 7 days; n=0', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'High on aspirin platelet reactivity', 'notes': 'High on aspirin platele reactivity defined as collagene AUC \\> 500', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Platelet Inhibition Measured With Optical Aggregometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-resuscitated Myocardial Infarction', 'description': 'diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial\n\ndiagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements'}, {'id': 'OG001', 'title': 'Resuscitated Myocardial Infarction', 'description': 'diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria\n\ndiagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '182'}, {'value': '253.8', 'groupId': 'OG001', 'lowerLimit': '122.7', 'upperLimit': '352.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day 3', 'description': 'Median (Inter-Quartile Range) Collagen AUC values on Day 3 measured with optical aggregometry The more light signal is detected, the better thrombocyte function is.', 'unitOfMeasure': 'AU*min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-resuscitated Myocardial Infarction', 'description': 'diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial\n\ndiagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique'}, {'id': 'OG001', 'title': 'Resuscitated Myocardial Infarction', 'description': 'diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria\n\ndiagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-resuscitated Myocardial Infarction', 'description': 'diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial\n\ndiagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique'}, {'id': 'FG001', 'title': 'Resuscitated Myocardial Infarction', 'description': 'diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria\n\ndiagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-resuscitated Myocardial Infarction', 'description': 'diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial\n\ndiagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique'}, {'id': 'BG001', 'title': 'Resuscitated Myocardial Infarction', 'description': 'diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria\n\ndiagnostic analysis of platelet function: analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'groupId': 'BG000', 'lowerLimit': '59.3', 'upperLimit': '72.7'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '75.8'}, {'value': '64.5', 'groupId': 'BG002', 'lowerLimit': '60.5', 'upperLimit': '72.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Collagen AUC day 1', 'classes': [{'categories': [{'measurements': [{'value': '219', 'groupId': 'BG000', 'lowerLimit': '80.5', 'upperLimit': '334.5'}, {'value': '69.5', 'groupId': 'BG001', 'lowerLimit': '46.7', 'upperLimit': '195.6'}, {'value': '185.8', 'groupId': 'BG002', 'lowerLimit': '77', 'upperLimit': '244'}]}]}], 'paramType': 'MEDIAN', 'description': 'Aspirin reactivity was monitored by inducing platelet aggregation with 2 µg/mL collagen and 0.5 mmol L-1 arachidonic acid (AA, Chronolog Corp., Havertown, PA, USA), respectively.\n\nFirst measurement was on day one and thus represents baseline.', 'unitOfMeasure': 'AU*min', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2016-05-12', 'resultsFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-02', 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet Inhibition Measured With Optical Aggregometry', 'timeFrame': 'day 3', 'description': 'Median (Inter-Quartile Range) Collagen AUC values on Day 3 measured with optical aggregometry The more light signal is detected, the better thrombocyte function is.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Cumulative Clinical Endpoint of Death and Stent Thrombosis', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute ST Segment Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '14737006', 'type': 'BACKGROUND', 'citation': 'McNicol A, Israels SJ. Platelets and anti-platelet therapy. J Pharmacol Sci. 2003 Dec;93(4):381-96. doi: 10.1254/jphs.93.381.'}, {'pmid': '14592562', 'type': 'BACKGROUND', 'citation': 'Tendera M, Wojakowski W. Role of antiplatelet drugs in the prevention of cardiovascular events. Thromb Res. 2003 Jun 15;110(5-6):355-9. doi: 10.1016/j.thromres.2003.08.003.'}, {'pmid': '12796140', 'type': 'BACKGROUND', 'citation': "Gurbel PA, Bliden KP, Hiatt BL, O'Connor CM. Clopidogrel for coronary stenting: response variability, drug resistance, and the effect of pretreatment platelet reactivity. Circulation. 2003 Jun 17;107(23):2908-13. doi: 10.1161/01.CIR.0000072771.11429.83. Epub 2003 Jun 9."}, {'pmid': '19550060', 'type': 'BACKGROUND', 'citation': 'Puri KS, Suresh KR, Gogtay NJ, Thatte UM. Declaration of Helsinki, 2008: implications for stakeholders in research. J Postgrad Med. 2009 Apr-Jun;55(2):131-4. doi: 10.4103/0022-3859.52846.'}, {'pmid': '19007592', 'type': 'BACKGROUND', 'citation': 'Siller-Matula JM, Lang I, Christ G, Jilma B. Calcium-channel blockers reduce the antiplatelet effect of clopidogrel. J Am Coll Cardiol. 2008 Nov 4;52(19):1557-63. doi: 10.1016/j.jacc.2008.07.055.'}, {'pmid': '30445678', 'type': 'DERIVED', 'citation': 'Pruller F, Bis L, Milke OL, Fruhwald F, Patzold S, Altmanninger-Sock S, Siller-Matula J, von Lewinski F, Ablasser K, Sacherer M, von Lewinski D. Cangrelor Induces More Potent Platelet Inhibition without Increasing Bleeding in Resuscitated Patients. J Clin Med. 2018 Nov 15;7(11):442. doi: 10.3390/jcm7110442.'}]}, 'descriptionModule': {'briefSummary': 'Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath lab. Therapy usually consists of one or more stent implantations. After implantation of a coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, knowledge of the individual platelet function is valuable.\n\nSeveral factors potentially promote a delayed or reduced mode of action of platelet function inhibitors in resuscitated patients:\n\n1. oral administration is impossible and medication needs to be administered via a gastric line.\n2. gastric absorption is delayed after resuscitation\n3. according to current guidelines patients are treated with therapeutic hypothermia. Including the time of rewarming cooling period is \\~48h', 'detailedDescription': 'Patients after successful resuscitation associated to a myocardial infarction will be included into the study the morning after the index event. Patients get dual platelet inhibition at the discretion of the interventionist. Patients are treated with therapeutic hypothermia according to the local Standard operating procedure for 24h and rewarming is performed within an additional 20h. Platelet function is measured every morning and Aspirin mediated as well as P2Y12 (purinergic G protein-coupled receptors-12)-inhibition mediated platelet function inhibition is recorded. All relevant clinical data including APACHE (Acute Physiology and Chronic Health Evaluation) and SOFA ( Sequential Organ Failure Assessment score) scores are collected.\n\nThe degree of platelet inhibition over time (7 days) and differences between the three drugs tested will be evaluated by optical aggregometry and by using the commercial VerifyNow test system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients surviving the first night after resuscitation due to myocardial infarction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myocardial infarction\n* dual platelet inhibition\n* resuscitation\n* therapeutic hypothermia\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02914795', 'briefTitle': 'Platelet Function in Resuscitated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Platelet Function in Resuscitated Patients', 'orgStudyIdInfo': {'id': '27-290ex14/15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-resuscitated myocardial infarction', 'description': 'diagnostic analysis of platelet function of a matched historical cohort of the ATLANTIS-ACS trial', 'interventionNames': ['Other: diagnostic analysis of platelet function']}, {'label': 'resuscitated myocardial infarction', 'description': 'diagnostic analysis of platelet function of the patient cohort included according to the inclusion criteria', 'interventionNames': ['Other: diagnostic analysis of platelet function']}], 'interventions': [{'name': 'diagnostic analysis of platelet function', 'type': 'OTHER', 'description': 'analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique', 'armGroupLabels': ['non-resuscitated myocardial infarction', 'resuscitated myocardial infarction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Dirk von Lewinski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}