Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-01 @ 11:37 PM
Study NCT ID:
NCT01402804
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2011-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NSAIDs in Coronary Artery Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-08', 'studyFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thromboxane-levels and light-transmission aggregometry in response to arachidonic acid', 'timeFrame': 'During hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['CAD']}, 'referencesModule': {'references': [{'pmid': '28262342', 'type': 'DERIVED', 'citation': 'Achilles A, Mohring A, Dannenberg L, Piayda K, Levkau B, Hohlfeld T, Zeus T, Kelm M, Polzin A. Analgesic medication with dipyrone in patients with coronary artery disease: Relation to MACCE. Int J Cardiol. 2017 Jun 1;236:76-81. doi: 10.1016/j.ijcard.2017.02.122. Epub 2017 Feb 27.'}], 'seeAlsoLinks': [{'url': 'http://www.uniklinik-duesseldorf.de/kardiologie', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Introduction:\n\nDifferent groups already showed in retrospective subgroup analyses, that there is an increased risk for cardiovascular events in patients on a simultaneous ASA/NSAID treatment.\n\nMethods:\n\nLight-Transmission aggregometry\n\nHypothesis:\n\nSimultaneous administration of different NSAIDs and ASA impair the platelet inhibiting effect of ASA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a stable CAD undergoing coronary angiography in the Universitätsklinik Düsseldorf.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients on a simultaneous ASA, NSAID treatment\n* \\> 18 years\n\nExclusion Criteria:\n\n* unconsciousness, not able to consent\n* reanimation, cardiac shock'}, 'identificationModule': {'nctId': 'NCT01402804', 'briefTitle': 'NSAIDs in Coronary Artery Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Non-steroidal Anti-inflammatory Drugs Impair the Platelet Inhibiting Effect of Acetylsalicylic Acid in Coronary Artery Disease Patients', 'orgStudyIdInfo': {'id': 'AGP-0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stable CAD, ASA, NSAID'}, {'label': 'Stable CAD, ASA'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Heinrich-Heine-University', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Amin Polzin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Kariologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf'}, {'name': 'Tobias Zeus, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinik für Kardiologie, Pneumologie und Angiologie'}, {'name': 'Thomas Hohlfeld, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut für Pharmakologie und Klinische Pharmakologie, Heinrich-Heine-Univerität Düsseldorf'}, {'name': 'Malte Kelm, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Heinrich-Heine University, Duesseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorFullName': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}