Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT02264912
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2014-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2016}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2014-10-09', 'studyFirstSubmitQcDate': '2014-10-14', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'laboratory efficacy of antiplatelet drugs measured as residual platelet reactivity, incidence of major adverse cardiovascular events and bleeding complications', 'timeFrame': 'During the 12 months after implantation of an intracoronary stent'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antiplatelets, percutanous coronary intervention, acute coronary syndromes, laboratory efficacy'], 'conditions': ['Platelet Aggregation Onhibitors']}, 'referencesModule': {'references': [{'pmid': '22154314', 'type': 'RESULT', 'citation': 'Motovska Z, Odvodyova D, Fischerova M, Stepankova S, Maly M, Morawska P, Widimsky P. Renal function assessed using cystatin C and antiplatelet efficacy of clopidogrel assessed using the vasodilator-stimulated phosphoprotein index in patients having percutaneous coronary intervention. Am J Cardiol. 2012 Mar 1;109(5):620-3. doi: 10.1016/j.amjcard.2011.10.019. Epub 2011 Dec 10.'}, {'pmid': '24728851', 'type': 'RESULT', 'citation': 'Motovska Z, Ondrakova M, Doktorova M, Widimsky P. Severe left ventricular systolic dysfunction is independently associated with high on-clopidogrel platelet reactivity. Am J Cardiovasc Drugs. 2014 Aug;14(4):313-8. doi: 10.1007/s40256-014-0074-3.'}, {'pmid': '26797336', 'type': 'RESULT', 'citation': 'Ondrakova M, Knot J, Ulman J, Maly M, Motovska Z. Efficacy of P2Y12 receptor antagonists in patients with atrial fibrillation according to the CHA2DS2VASc score. Int J Cardiol. 2016 Mar 15;207:84-6. doi: 10.1016/j.ijcard.2016.01.039. Epub 2016 Jan 6. No abstract available.'}, {'pmid': '25917561', 'type': 'RESULT', 'citation': 'Motovska Z, Ondrakova M, Bednar F, Knot J, Ulman J, Maly M. Selection of P2Y12 antagonist, treatment initiation, and predictors of high on-treatment platelet reactivity in a "Real World" registry. Thromb Res. 2015 Jun;135(6):1093-9. doi: 10.1016/j.thromres.2015.04.014. Epub 2015 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'The ongoing LAPCOR (Laboratory AntiPlatelet efficacy and Clinical Outcome Registry) registry was initiated in 2008 at a tertiary care cardiac center, and consecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed on urgent or elective basis.Patients were included in the registry after having signed an informed consent for participation. No exclusion criterion has been applied for the registry participation. Efficacy of P2Y12 receptor antagonists has been measured by quantitative flow cytometric analysis of vasodilator-stimulated phosphoprotein (VASP) phosphorylation according to the manufacturer protocol (Platelet VASP; Diagnostica Stago, Biocytex, Asnières, France) on a FACScan flow cytometer (Becton Dickinson). Occurrence of major adverse cardiac events at 30 days, 6-months and one year follow up has been investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were included in the registry after having signed an informed consent for participation. No exclusion criterion has been applied for the registry participation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients after stent PCI treated with P2Y12 antagonist\n* Written informed consent\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT02264912', 'acronym': 'LAPCOR', 'briefTitle': 'The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty Hospital Kralovske Vinohrady'}, 'officialTitle': 'The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry', 'orgStudyIdInfo': {'id': '05-2008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'stent-PCI patients', 'description': 'Consecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed on urgent or elective basis.', 'interventionNames': ['Drug: antiplatelet drugs - P2Y12 antagonists']}], 'interventions': [{'name': 'antiplatelet drugs - P2Y12 antagonists', 'type': 'DRUG', 'otherNames': ['clopidogrel, prasugrel, ticagrelor'], 'armGroupLabels': ['stent-PCI patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10034', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Faculty Hospital Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Zuzana Motovska, MD.PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty Hospital Kralovske Vinohrady'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty Hospital Kralovske Vinohrady', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD. PhD. FESC.', 'investigatorFullName': 'Zuzana Motovska', 'investigatorAffiliation': 'Faculty Hospital Kralovske Vinohrady'}}}}