Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-29 @ 7:11 PM
Study NCT ID:
NCT03049566
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2017-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Acetylsalicylic Acid Before Non-cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 805}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative discontinuation of acetylsalicylic acid medication', 'timeFrame': '1 day', 'description': 'questionnaires (cross-sectional observation during preoperative assessment)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bleeding', 'Adverse Cardiac Events', 'Adherence, Medication', 'Aspirin', 'Acetylsalicylic acid'], 'conditions': ['Surgery', 'Platelet Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study aims to assess independent factors associated with the clinical decision to discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery.', 'detailedDescription': 'Acetylsalicylic acid (ASA) is widely used for primary and secondary prevention of cardiovascular diseases. A prothrombotic rebound phenomenon after aspirin cessation has been reported. ASA withdrawal is associated with an increased incidence of adverse cardiac events. In individuals with previous percutaneous coronary intervention (PCI), cessation of ASA may cause stent thrombosis or myocardial infarction. However, many patients undergo non-cardiac surgery within the first two years after PCI. Perioperatively, two counteracting risks have to be taken into account, first, the risk of thromboembolic complications, if ASA medication is discontinued and second, the risk of surgical bleeding, if ASA therapy is continued. However, factors contributing to preoperative decision-making for ASA-withdrawal are still unclear.\n\nThis study aims to assess independent factors associated with the clinical decision to discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery. In particular this study aims to determine if the presence of coronary stents is independently associated with ASA discontinuation. Furthermore this study assesses, if benefit-risk-estimates (numerical rating scales) of the patients and the supervising physicians are associated with the decision to withdraw ASA.\n\nStudy design\n\nPatients on long-term ASA undergoing non-cardiac surgery as well as their supervising anesthesiologist participate in a preoperative survey. Detailed information about ASA medication, perioperative ASA use, comorbidities, factors that might be associated with the decision to discontinue ASA preoperatively and benefit-risk-estimates (numerical rating scales) are sampled by questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective non-cardiac surgery, who present in the pre-assessment clinic of the University Medical Center Hamburg-Eppendorf during the study recruitment period, are screened for eligibility.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 Years and older\n* Scheduled for elective non-cardiac surgery\n* Regular long-term ASA use, defined as daily low-dose (≤100mg) ASA therapy, even if ASA-medication was interrupted within the last 30 days before study inclusion\n\nExclusion Criteria:\n\n* \\< 18 Years\n* No consent given'}, 'identificationModule': {'nctId': 'NCT03049566', 'briefTitle': 'Low-dose Acetylsalicylic Acid Before Non-cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Discontinuation of Low-dose Acetylsalicylic Acid Before Elective Non-cardiac Surgery: a Preoperative Monocentric Cross-sectional Study', 'orgStudyIdInfo': {'id': 'WF03013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'preoperative questionnaires', 'description': 'Patients on long-term acetylsalicylic acid undergoing non-cardiac surgery', 'interventionNames': ['Other: preoperative questionnaires']}], 'interventions': [{'name': 'preoperative questionnaires', 'type': 'OTHER', 'description': 'no intervention, cross-sectional survey in a single group', 'armGroupLabels': ['preoperative questionnaires']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'facility': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Christian Zöllner, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf'}, {'name': 'Martin Petzoldt, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}