Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-02-22 @ 1:51 PM
Study NCT ID:
NCT04848766
Status:
UNKNOWN
Last Update Posted:
2021-06-08
First Post:
2021-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IPD Meta-analysis of De-escalation Treatment Strategy After PCI in ACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-07', 'studyFirstSubmitDate': '2021-04-10', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net adverse clinical and cerebral events (NACCE)', 'timeFrame': '1 year after intervention', 'description': 'composite of all-cause death, myocardial infarction, coronary revascularization, stroke and major bleeding.'}], 'secondaryOutcomes': [{'measure': 'Composite endpoint of Major adverse cardiovascular outcomes', 'timeFrame': '1 year after intervention', 'description': 'all-cause mortality, myocardial infarction, coronary revascularization, stroke'}, {'measure': 'Major Bleeding outcome defined by the Bleeding Academic Research Consortium (BARC) criteria', 'timeFrame': '1 year after intervention', 'description': 'Bleeding outcomes, defined by the Bleeding Academic Research Consortium criteria'}, {'measure': 'Individual components of the primary outcome', 'timeFrame': '1 year after intervention', 'description': 'all-cause mortality'}, {'measure': 'Individual components of the primary outcome', 'timeFrame': '1 year after intervention', 'description': 'cardiovascular mortality'}, {'measure': 'Individual components of the primary outcome', 'timeFrame': '1 year after intervention', 'description': 'non-cardiovascular mortality'}, {'measure': 'Individual components of the primary outcome', 'timeFrame': '1 year after intervention', 'description': 'myocardial infarction'}, {'measure': 'Individual components of the primary outcome', 'timeFrame': '1 year after intervention', 'description': 'stroke'}, {'measure': 'Individual components of the primary outcome', 'timeFrame': '1 year after intervention', 'description': 'any coronary revascularization'}, {'measure': 'Individual components of the primary outcome', 'timeFrame': '1 year after intervention', 'description': 'any bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['percutaneous coronary intervention', 'dual antiplatelet therapy', 'de-escalation'], 'conditions': ['Acute Coronary Syndrome', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies.', 'detailedDescription': 'This is an individual patient-level data meta-analysis (IPD Meta-analysis). This study population was incorporated from studies that were previoiusly published.\n\nWe will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies. The electronic search strategy was complemented by manual examination of references cited by included articles, recent reviews, editorials, and meta-analyses. No restrictions were imposed on language, study period, or sample size. The search keywords include "acute coronary syndrome", "ACS", "primary", "percutaneous coronary intervention", "PCI", "de-escalation", "guided", "guide", "antiplatelet", "P2Y12 inhibitor", "P2Y12", "dual antiplatelet therapy", "DAPT".\n\nArticles were included when they met the following prespecified criteria: (1) included the ACS patients who underwent PCI with drug-eluting stent (DES); (2) maintained DAPT for 1 year; (3) de-escalation strategy of DAPT was clearly defined; (4) clinical outcomes, including ischemic and bleeding events, were clearly reported; (5) randomized controlled trials were considered for inclusion. Two independent investigators screened titles and abstracts, identified duplicated studies, performed full-article reviews, and determined the study inclusion. The third investigator supervised the searching process and adjudicated all the disagreements.\n\nAfter selecting eligible RCTs, we will incorporate all known randomized controlled trials requesting individual patient data from the principal investigator of each trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'As above', 'eligibilityCriteria': 'This study is a meta-analysis of previously published studies. Therefore, the eligibility criteria may be diverse according to the individual studies.\n\n\\--------------------------\n\nInclusion Criteria:\n\n* Subject must have clinical diagnosis of acute coronary syndrome\n\nExclusion Criteria:\n\n* The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor'}, 'identificationModule': {'nctId': 'NCT04848766', 'briefTitle': 'IPD Meta-analysis of De-escalation Treatment Strategy After PCI in ACS', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of De-escalation Treatment Strategy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'De-escal-meta'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'De-escalation treatment group', 'description': 'Patients diagnosed as acute coronary syndrome, and who receive de-escalation antiplatelet therapy after percutaneous coronary intervention', 'interventionNames': ['Drug: De-escalation Treatment Strategy of dual antiplatelet therapy']}, {'label': 'Conventional treatment group', 'description': 'Patients diagnosed as acute coronary syndrome, and who receive conventional (non-de-escalation) antiplatelet therapy after percutaneous coronary intervention'}], 'interventions': [{'name': 'De-escalation Treatment Strategy of dual antiplatelet therapy', 'type': 'DRUG', 'description': 'Patients receive de-escalation treatment of dual antiplatelet therapy after percutaneous coronary intervention', 'armGroupLabels': ['De-escalation treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyo-Soo Kim, MD', 'role': 'CONTACT', 'email': 'hyosoo@snu.ac.kr'}, {'name': 'Jeehoon Kang, MD', 'role': 'CONTACT', 'email': 'medikang@gmail.com'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyo-Soo Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hyosoo@snu.ac.kr', 'phone': '82-2-2072-2226'}, {'name': 'Jeehoon Kang, MD', 'role': 'CONTACT', 'email': 'medikang@gmail.com', 'phone': '82-2-2072-2677'}], 'overallOfficials': [{'name': 'Kyung Woo Park, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data sharing will be decided after discussed with the principle investigators of each study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Antonius Hospital', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyo-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}