[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-bleeding-risk-hbr\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-bleeding-risk-hbr":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100620223","optimization-and-validation-of-quality-control-indicators-for-coronary-revascularization-based-on-antiplatelet-therapy-100620223",false,"NCT07354828","Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy","Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy: Establishment of a Quality Control Standard System for Coronary Revascularization in Coronary Heart Disease Based on Dual Antiplatelet Therapy (DAPT)","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Clinically diagnosed with ACS and received implantation of at least one drug-eluting stent (DES)\n* Meets 1 major criterion or 2 minor criteria of the ARC-HBR high-bleeding-risk definition\n* Able to complete the OPT-CAD score calculation\n* Judged by the investigator to tolerate DAPT for at least 12 months\n* Signed the informed consent form\n\nExclusion Criteria:\n\n* Allergy to study medications such as aspirin, clopidogrel, or ticagrelor\n* Occurrence of major ischemic or bleeding events during the current hospitalization\n* Presence of other severe diseases with a life expectancy of less than one year\n* Pregnancy, or women of childbearing potential who plan to become pregnant within one year\n* Current participation in another clinical study and still within its observation period.","ALL","18 Years",{"count":19,"type":20},3500,"ESTIMATED","12 Months","OBSERVATIONAL","Study Purpose Coronary heart disease (CAD) is a leading global cause of death, with Acute Coronary Syndrome (ACS) as its acute and life-threatening subtype. Percutaneous Coronary Intervention (PCI) plus stent implantation is the first-line treatment for ACS, and post-PCI Dual Antiplatelet Therapy (DAPT, aspirin + P2Y₁₂ inhibitor) is core for thrombosis prevention but increases bleeding risk. Approximately 40% of ACS patients are classified as High Bleeding Risk (HBR). China lacks a unified DAPT quality control system, and the predictive value of the OPT-CAD ischemic risk score for this population remains unvalidated. This study aims to: 1) Evaluate the feasibility and influencing factors of the DAPT quality control system in HBR ACS patients post-PCI; 2) Verify the accuracy of the OPT-CAD score in predicting ischemic risk, providing evidence for personalized treatment.\n\nEligibility Criteria Inclusion Criteria Aged ≥18 years; Diagnosed with ACS and implanted with at least one drug-eluting stent (DES) during PCI; Meets ARC-HBR (Academic Research Consortium for High Bleeding Risk) HBR definition (1 major criterion or 2 minor criteria); Able to complete OPT-CAD scoring; Tolerates 12-month DAPT (physician assessment); Signs informed consent. Exclusion Criteria Allergy to aspirin, clopidogrel, ticagrelor, or other study-related antiplatelet drugs; Severe ischemia or major bleeding during current hospitalization; Terminal illness with life expectancy \\\u003C1 year; Pregnant or planning pregnancy within 1 year; Enrolled in other ongoing clinical studies. Study Process\n\nThis is a multi-center prospective cohort study (we will follow eligible patients over 12 months to collect real-world data without changing their standard care) recruiting 3,500 participants nationwide. Post-enrollment:\n\nReceive 6-12 months of standard DAPT (regimen determined by your physician); Follow-ups at 1 month (±7 days), 3 months (±14 days), 6 months (±30 days), and 12 months (±30 days) post-PCI (via phone or outpatient visit) to collect medication adherence, bleeding\u002Fischemic events, and clinical outcomes; Confidential data collection via a secure Electronic Data Capture (EDC) system. Study Endpoints Primary Endpoints Feasibility of the DAPT quality control system, inter-hospital differences in DAPT use, 6-12 month DAPT completion rate, and impact of DAPT interruption on patient outcomes; Accuracy of the OPT-CAD score in predicting ischemic risk for HBR patients. Secondary Endpoints 12-month bleeding event rates (BARC 1-5 types, including minor bleeding like puncture site bleeding and major bleeding like intracranial hemorrhage); 12-month ischemic event rates (including target lesion failure-cardiac death, target vessel-related myocardial infarction, or target lesion revascularization-all-cause death, ischemic stroke, definite stent thrombosis, etc.); DAPT interruption rate, P2Y₁₂ inhibitor discontinuation rate (≥1 week), and aspirin discontinuation rate (≥1 week).\n\nKey Information for Participants Voluntary participation: You may withdraw anytime without penalty or loss of medical benefits; Confidential data protection: Personal information will be anonymized with a unique study ID; Free study-related assessments and follow-ups; Prompt medical care will be provided for any adverse events. For inquiries, contact the study team at the participating hospital.",[25,26,27],"Acute Coronary Syndrome (ACS)","High Bleeding Risk (HBR)","Coronary Artery Disease (CAD)",[29,25,26,30,31,32,33,34,35,36,37,38,39],"Dual Antiplatelet Therapy (DAPT)","Percutaneous Coronary Intervention (PCI)","OPT-CAD Score","Quality Control Indicators","Coronary Revascularization","Prospective Cohort Study","Real-World Research","Bleeding Events","Ischemic Events","Medication Adherence","Post-PCI Prognosis","NOT_YET_RECRUITING","2026-01-12",{"date":43,"type":44},"2026-01-21","ACTUAL",{"date":46,"type":20},"2025-12-30",{"date":48,"type":20},"2029-06-30",{"name":50,"class":51},"Shenyang Northern Hospital","OTHER"]