Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-04 @ 3:00 PM
Study NCT ID:
NCT04999293
Status:
COMPLETED
Last Update Posted:
2021-08-10
First Post:
2021-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1505}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-05', 'studyFirstSubmitDate': '2021-08-05', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium', 'timeFrame': '12 months', 'description': 'The primary safety endpoint'}, {'measure': 'Combined major adverse cardiovascular and cerebrovascular events (MACCEs), including all-cause mortality, myocardial infarction, ischemic stroke, and any revascularization.', 'timeFrame': '12 months', 'description': 'The primary efficacy endpoint'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '12 months'}, {'measure': 'Myocardial infarction', 'timeFrame': '12 months'}, {'measure': 'Revascularization', 'timeFrame': '12 months'}, {'measure': 'Ischemic stroke', 'timeFrame': '12 months'}, {'measure': 'Incidence of BARC3 and 5 bleeding', 'timeFrame': '12 months'}, {'measure': 'Incidence of major and minor bleeding defined by the PLATO study', 'timeFrame': '12 months'}, {'measure': 'Incidence of major and minor bleeding defined by the TIMI study', 'timeFrame': '12 months'}, {'measure': 'Occurrence of any bleeding', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Platelet Aggregation Inhibitors', 'Dual Anti-Platelet Therapy', 'Aged', 'Percutaneous Coronary Intervention']}, 'referencesModule': {'references': [{'pmid': '11520521', 'type': 'BACKGROUND', 'citation': 'Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA; Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001 Aug 18;358(9281):527-33. doi: 10.1016/s0140-6736(01)05701-4.'}, {'pmid': '19717846', 'type': 'BACKGROUND', 'citation': 'Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.'}, {'pmid': '22991347', 'type': 'BACKGROUND', 'citation': 'Husted S, James S, Becker RC, Horrow J, Katus H, Storey RF, Cannon CP, Heras M, Lopes RD, Morais J, Mahaffey KW, Bach RG, Wojdyla D, Wallentin L; PLATO study group. Ticagrelor versus clopidogrel in elderly patients with acute coronary syndromes: a substudy from the prospective randomized PLATelet inhibition and patient Outcomes (PLATO) trial. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):680-8. doi: 10.1161/CIRCOUTCOMES.111.964395.'}, {'pmid': '32334703', 'type': 'BACKGROUND', 'citation': 'Gimbel M, Qaderdan K, Willemsen L, Hermanides R, Bergmeijer T, de Vrey E, Heestermans T, Tjon Joe Gin M, Waalewijn R, Hofma S, den Hartog F, Jukema W, von Birgelen C, Voskuil M, Kelder J, Deneer V, Ten Berg J. Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial. Lancet. 2020 Apr 25;395(10233):1374-1381. doi: 10.1016/S0140-6736(20)30325-1.'}, {'pmid': '35400997', 'type': 'DERIVED', 'citation': 'Meng S, Guo L, Ye Z, Wang J, Ding H, Wu S, Huang R. Comparison of Clinical Outcomes Between Ticagrelor and Clopidogrel in Elderly Patients Undergoing Percutaneous Coronary Intervention: A Cohort Study. Clin Interv Aging. 2022 Apr 2;17:331-341. doi: 10.2147/CIA.S355210. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The study is an investigator-sponsored, retrospective cohort study designed to compare efficacy and safety of ticagrelor in elderly patients undergoing percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥75 years of age who were treated with PCI (limited to stent implantation) at the First Affiliated Hospital of Dalian Medical University from January 1, 2015 to December 31, 2019 were screened for additional enrollment criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥75 years old;\n* Treated with PCI (limited to stent implantation) ;\n* Survivors and treated with DAPT (aspirin \\[100 mg once daily\\], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist \\[clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)\\]) at discharge;\n\nExclusion Criteria:\n\n* Coronary artery bypass graft (CABG) or only drug conservative treatment during hospitalization;\n* Concurrent use of oral anticoagulants;\n* Inability to tolerate long-term antiplatelet therapy, such as active bleeding and a bleeding tendency;\n* Acute infectious diseases;\n* Cognitive impairment;\n* Declined re-examination.'}, 'identificationModule': {'nctId': 'NCT04999293', 'briefTitle': 'Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Dalian Medical University'}, 'officialTitle': 'Antiplatelet Therapy in Elderly Patients Undergoing Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'PJ-KS-KY-2021-146'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The Elderly Undergoing Percutaneous Coronary Intervention', 'description': 'Patients were survivors and treated with DAPT (aspirin \\[100 mg once daily\\], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist \\[clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)\\]) at the time of hospital discharge.All patients were followed for 1 year in the outpatient clinic after hospital discharge.', 'interventionNames': ['Drug: Ticagrelor']}], 'interventions': [{'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Clopidogrel'], 'description': 'Patients were survivors and treated with DAPT (aspirin \\[100 mg once daily\\], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist \\[clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)\\]) at the time of hospital discharge.All patients were followed for 1 year in the outpatient clinic after hospital discharge.', 'armGroupLabels': ['The Elderly Undergoing Percutaneous Coronary Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116011', 'city': 'Dalian', 'country': 'China', 'facility': 'The First Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}], 'overallOfficials': [{'name': 'Shaoke Meng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Dalian Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Meng Shaoke', 'investigatorAffiliation': 'The First Affiliated Hospital of Dalian Medical University'}}}}