[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620223":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":35,"collaborators":39,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":10,"enrollmentInfo":51,"targetDuration":54,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Shenyang Northern Hospital","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Low Ischemic Risk (OPT-CAD \u003C 90)",null,"This group includes patients with high bleeding risk (meeting ARC-HBR criteria) who are diagnosed with Acute Coronary Syndrome (ACS) and have undergone Percutaneous Coronary Intervention (PCI) with at least one Drug-Eluting Stent (DES) implantation. All participants have an OPT-CAD score \\\u003C 90, indicating low ischemic risk. They receive routine Dual Antiplatelet Therapy (DAPT) for 6-12 months as per clinical guidelines (specific regimens determined by attending physicians). During the 12-month follow-up, data on DAPT adherence, discontinuation reasons, and clinical outcomes (bleeding\u002Fischemic events, mortality) will be collected to compare with the moderate\u002Fhigh ischemic risk group.",{"label":13,"type":10,"description":14,"interventionNames":10},"Moderate\u002FHigh Ischemic Risk (OPT-CAD ≥ 90)","This group comprises patients who meet the same baseline criteria as Group 1: high bleeding risk (ARC-HBR positive), ACS diagnosis, PCI with DES implantation, and ability to tolerate 12-month DAPT. The key distinction is an OPT-CAD score ≥ 90, classifying them as moderate\u002Fhigh ischemic risk. They also receive standard 6-12 month DAPT (regimens decided by clinicians). Follow-up procedures and data collection are identical to Group 1, aiming to verify the predictive value of the OPT-CAD score by comparing clinical outcomes between the two groups.",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Haiwei Liu, Professor","CONTACT","024-288897260","ifoliuhw@sina.com",[22],{"facility":23,"status":10,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":10},"General Hospital of Northern Theater Command","Shenyang","Liaoning","110000","China","CN",{"type":30,"coordinates":31},"Point",[32,33],123.43278,41.79222,{"lat":33,"lon":32},{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Han Yaling","Director, clinical professor",[40],{"name":41,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital","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":52,"type":53},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.",[58,59,60],"Acute Coronary Syndrome (ACS)","High Bleeding Risk (HBR)","Coronary Artery Disease (CAD)",[62,58,59,63,64,65,66,67,68,69,70,71,72],"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":76,"type":77},"2026-01-21","ACTUAL",{"date":79,"type":53},"2025-12-30",{"date":81,"type":53},"2029-06-30",{"name":5,"class":6},1]