Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-01-07 @ 6:31 PM
Study NCT ID:
NCT03184805
Status:
TERMINATED
Last Update Posted:
2018-05-22
First Post:
2017-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'whyStopped': 'Investigator judged that this study can not be maintained because participant registration rate is low.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-17', 'studyFirstSubmitDate': '2017-06-07', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A composite of cardiac death', 'timeFrame': '1 day after discharging from the hospital', 'description': 'A composite of major perioperative adverse events'}, {'measure': 'nonfatal myocardial infarction (MI)', 'timeFrame': '1 day after discharging from the hospital', 'description': 'A composite of major perioperative adverse events'}, {'measure': 'cerebrovascular accident', 'timeFrame': '1 day after discharging from the hospital', 'description': 'A composite of major perioperative adverse events'}, {'measure': 'definite or probable stent thrombosis', 'timeFrame': '1 day after discharging from the hospital', 'description': 'A composite of major perioperative adverse events'}, {'measure': 'any revascularization and BARC(Bleeding Academic Research Consortium) ≥3 bleeding during index hospitalization for surgery or procedure', 'timeFrame': '1 day after discharging from the hospital', 'description': 'A composite of major perioperative adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).', 'detailedDescription': 'Most current guidelines recommend to focus on continuing antiplatelet therapy (mostly with aspirin) during noncardiac surgery if possible. Although previous study showed efficacy of continuous antiplatelet therapy in reducing perioperative ischemic cardiovascular events, its effectiveness is still not clear between perioperative bleeding and ischemic risk. Most previous trials support the absolute increase in bleeding risk with perioperative administration of antiplatelet. Furthermore, recent studies demonstrated that perioperative major bleeding may be related to increase cardiovascular risk. The investigators will compare the efficacy and safety of continuing versus stopping antiplatelet therapy during perioperative period in patients underwent PCI(Percutaneous Coronary Intervention) with next generation DES(Drug Eluting Stent).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19-85 years\n* Planning of elective noncardiac surgery or invasive procedure\n* At least 1 year interval between the surgery or procedure and last PCI with next generation DES\n* Currently on antiplatelet therapy\n\nExclusion Criteria:\n\n* PCI with BMS(bare metal stent), 1st generation DES or bioresorbable vascular scaffold\n* Total length of inserted DES in the 3 vessels \\>60 mm\n* History of stent thrombosis\n* History of coronary artery bypass grafting surgery\n* Planned surgery or procedure with high bleeding risk including followings: intracranial neurosurgery, spinal canal surgery, and eye posterior chamber surgery, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), ampullary resection, endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy plus large-balloon papillary dilation, endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) of cystic lesions\n* Left ventricular ejection fraction \\<40%\n* Myocardial infarction within 6 months\n* Any overt thromboembolism requiring medical surveillance and/or treatment\n* Any clinically overt sign of hemorrhage within 3 months\n* Anticoagulant therapy for any reason\n* Need of continuation or discontinuation of antiplatelet therapy during surgery or procedure at the discretion of cardiologist or operator\n* Any contraindication, adverse drug reaction or hypersensitivity to aspirin\n* Pregnant women or women with potential childbearing\n* Inability to understand or read the informed content'}, 'identificationModule': {'nctId': 'NCT03184805', 'briefTitle': 'STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Randomized Controlled Comparison: STOPping Versus Continuing Antiplatelet Therapy During Noncardiac Surgery and Procedures After Next Generation Drug-eluting Stent Implantation (STOP-ASP Trial)', 'orgStudyIdInfo': {'id': '4-2017-0241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuing aspirin', 'description': 'Patients in the group may continue the administration of aspirin during perioperative period.', 'interventionNames': ['Drug: Continuing aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Stopping aspirin', 'description': 'Patients in the group may stop medication of antiplatelet drugs during perioperative period.', 'interventionNames': ['Drug: Stopping aspirin']}], 'interventions': [{'name': 'Continuing aspirin', 'type': 'DRUG', 'description': 'Subject assigned to control arm will maintain antiplatelet therapy using aspirin only at least 7 days before surgery. If subject is taking one or more antiplatelet drugs, it should be changed (for subjects taking antiplatelet drug except aspirin at enrollment) or continued (for subject taking aspirin at enrollment) with low-dose, aspirin monotherapy before surgery. Cessation of clopidogrel, ticagrelor, and prasugrel should be started at least 5 days, 3 days and 7 days before surgery, respectively. Administration of aspirin will be started at the day of cessation of previous antiplatelet regimen and maintained until third postoperative day with 100 mg once a day.', 'armGroupLabels': ['Continuing aspirin']}, {'name': 'Stopping aspirin', 'type': 'DRUG', 'description': 'Subject assigned to comparison arm will stop antiplatelet therapy before scheduled surgery or procedure. If subject is taking aspirin, clopidogrel, ticagrelor, or prasugrel, it should be discontinued for 7 days, 5 days, 3-5 days, and 7 days before surgery. Antiplatelet therapy may be restarted as previous regimen at fourth postoperative day or sooner unless significant bleeding risk or bleeding event occurs.', 'armGroupLabels': ['Stopping aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}