Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT06241833
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emulation of Randomized Clinical Trial in Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'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': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118420}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-24', 'studyFirstSubmitDate': '2024-01-28', 'studyFirstSubmitQcDate': '2024-01-28', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of Major GI bleeding requiring transfusion', 'timeFrame': '1-year follow-up', 'description': 'Efficacy outcome'}, {'measure': 'Rates of Major adverse cardiac event', 'timeFrame': '1-year follow-up', 'description': 'Safety outcome, a composite of cardiac death, MI, ischemic stroke, and repeat revascularization'}], 'secondaryOutcomes': [{'measure': 'Rates of Major or Minor GI bleeding with hospitalization', 'timeFrame': '1-year follow-up', 'description': 'Efficacy outcome'}, {'measure': 'Rates of Cardiac death', 'timeFrame': '1-year follow-up', 'description': 'Cardiac death'}, {'measure': 'Rates of Spontaneous MI', 'timeFrame': '1-year follow-up', 'description': 'Spontaneous MI'}, {'measure': 'Rates of Ischemic stroke', 'timeFrame': '1-year follow-up', 'description': 'Ischemic stroke'}, {'measure': 'Rates of Repeat revascularization', 'timeFrame': '1-year follow-up', 'description': 'Repeat revascularization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention', 'Cardiovascular Pharmacotherapy', 'Proton pump inhibitor', 'Dual antiplatelet therapy'], 'conditions': ['Myocardial Infarction', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '39962947', 'type': 'DERIVED', 'citation': 'Kang D, Choi KH, Park H, Heo J, Park TK, Lee JM, Cho J, Yang JH, Song YB, Choi SH, Gwon HC, Hahn JY. Effects of proton pump inhibitors on gastrointestinal bleeding and cardiovascular outcomes in myocardial infarction patients treated with DAPT. EuroIntervention. 2025 Feb 17;21(4):e229-e239. doi: 10.4244/EIJ-D-24-00673.'}]}, 'descriptionModule': {'briefSummary': "Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.", 'detailedDescription': 'This is a non-randomized, non-interventional study from Korean National Health Insurance Service database. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with AMI undergoing PCI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- PCI with MI (I21) admission\n* Age more than 40 or less than 80 years old\n* Aspirin and Clopidogrel/Prasugrel/Ticagrelor prescription with more than 2 days at discharge\n\nExclusion Criteria:\n\n* \\- Previous use of a PPI, an H2-receptor antagonist, sucralfate, or misoprostol within 30 days before admission\n* Preexisting cancer within a year before admission\n* History of RBC transfusion\n* RBC transfusion in admission\n* Cardiogenic Shock\n* Length of stay more than 14 days\n* OAC prescription with more than 2 days at discharge\n* H2 prescription with more than 2 days at discharge'}, 'identificationModule': {'nctId': 'NCT06241833', 'acronym': 'RCT-BigData', 'briefTitle': 'Emulation of Randomized Clinical Trial in Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Effects of PPI on GI Bleeding and Cardiovascular Outcomes Among Post-MI Patients Taking DAPT', 'orgStudyIdInfo': {'id': 'CVD-Emulation'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PPI group', 'description': 'Patients receiving PPI concomitant with dual antiplatelet therapy after PCI for AMI', 'interventionNames': ['Drug: PPI']}, {'label': 'no PPI group', 'description': 'Patients receiving dual antiplatelet therapy only after PCI for AMI'}], 'interventions': [{'name': 'PPI', 'type': 'DRUG', 'otherNames': ['GI protection'], 'description': 'use of PPI concomitant with DAPT', 'armGroupLabels': ['PPI group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ki Hong Choi, MD', 'role': 'CONTACT', 'email': 'cardiokh@gmail.com', 'phone': '82-2-3410-3419'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ki Hong Choi, MD', 'role': 'CONTACT', 'email': 'cardiokh@gmail.com', 'phone': '82-2-3410-3419'}, {'name': 'Danbee Kang, PhD', 'role': 'CONTACT', 'email': 'dbee.kang@skku.edu', 'phone': '82-2-2148-7197'}], 'overallOfficials': [{'name': 'Ki Hong Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ki Hong Choi', 'investigatorAffiliation': 'Samsung Medical Center'}}}}