[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658025":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":29,"studyPopulation":20,"armGroups":30,"interventions":43,"overallOfficials":20,"centralContacts":58,"locations":68,"responsibleParty":88,"collaborators":20,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":20,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Jilin University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)","Composite endpoint including cardiovascular death, non-fatal myocardial infarction, definite or probable stent thrombosis, and ischemic stroke, independently adjudicated by a blinded clinical endpoint committee.","12 months after randomization",[14,17],{"measure":15,"description":16,"timeFrame":12},"Incidence of Clinically Relevant Bleeding Events","Bleeding events classified by the Bleeding Academic Research Consortium (BARC) criteria, including BARC grade 2, 3 and 5.",{"measure":18,"description":19,"timeFrame":12},"Net Adverse Clinical Events (NACE)","Composite of all-cause death, myocardial infarction, ischemic stroke and major bleeding.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","This is a multicenter, randomized, open-label, active-controlled, non-inferiority trial with two parallel arms. Eligible participants will be randomly assigned at a 1:1 ratio to receive either low-dose aspirin (50 mg once daily) or standard-dose aspirin (100 mg once daily), both in combination with a P2Y12 inhibitor. All participants will be followed for 12 months after randomization.","TREATMENT",{"masking":27,"maskingDescription":28,"whoMasked":20},"NONE","Although the trial is open-label for participants and treating clinicians, an independent Clinical Endpoint Committee (CEC) is masked to treatment assignment when adjudicating all endpoint events (ischemic events and bleeding events) to minimize assessment bias.","Background Dual antiplatelet therapy (DAPT) - aspirin combined with a P2Y12 inhibitor - is the standard of care to prevent stent thrombosis and ischemic events after PCI. However, the optimal aspirin dose in combination with modern P2Y12 inhibitors remains undefined, especially in Chinese populations. Current practice widely uses 100 mg daily aspirin, but pharmacological and clinical evidence suggests that lower doses may achieve comparable antiplatelet effect with a lower bleeding risk.\n\nStudy Design This is a multicenter, randomized, open-label, active parallel-controlled non-inferiority trial. Enrollment will include 2640 adults with acute or chronic coronary syndrome who have undergone successful PCI and are scheduled for at least 12 months of DAPT. Randomization will be stratified by study center with a 1:1 allocation ratio.\n\nTreatment Regimens\n\n* Experimental group: enteric-coated aspirin 50 mg once daily + a P2Y12 inhibitor\n* Control group: enteric-coated aspirin 100 mg once daily + a P2Y12 inhibitor The choice of P2Y12 inhibitor (ticagrelor or clopidogrel) is at the treating physician's discretion based on patient characteristics and clinical guidelines. DAPT will be maintained for a minimum of 12 months.\n\nOutcome Assessment All suspected endpoint events will be independently adjudicated by a blinded Clinical Endpoint Committee according to standardized international definitions. A Data Monitoring Committee will periodically review safety data and study conduct.\n\nFollow-up visits are scheduled at 1 month, 6 months, and 12 months after randomization, including clinical assessment, medication adherence evaluation, and event verification.",[31,38],{"label":32,"type":33,"description":34,"interventionNames":35},"Low-dose Aspirin","EXPERIMENTAL","Participants receive enteric-coated aspirin 50 mg once daily, combined with a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily), for at least 12 months after successful percutaneous coronary intervention.",[36,37],"Drug: Aspirin","Drug: P2Y12 inhibitor",{"label":39,"type":40,"description":41,"interventionNames":42},"Standard-dose Aspirin","ACTIVE_COMPARATOR","Participants receive enteric-coated aspirin 100 mg once daily, combined with a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily), for at least 12 months after successful percutaneous coronary intervention.",[36,37],[44,51],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","Aspirin","Enteric-coated aspirin for oral administration, once daily. Two dose levels are studied: 50 mg in the experimental arm and 100 mg in the active comparator arm.",[32,39],[50],"Acetylsalicylic Acid",{"type":45,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"P2Y12 inhibitor","Background antiplatelet therapy used in both study arms. Either ticagrelor 90 mg orally twice daily or clopidogrel 75 mg orally once daily, prescribed at the treating physician's discretion according to clinical guidelines.",[32,39],[56,57],"Ticagrelor","Clopidogrel",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":20,"email":63},"Qian Tong, MD","CONTACT","'+86-13074337289'","tongqian187@aliyun.com",{"name":65,"role":61,"phone":66,"phoneExt":20,"email":67},"Mingyou 'Zhang', MD","+86-13689842200","zmy@jlu.edu.cn",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"First Hospital of Jilin University","RECRUITING","Changchun","Jilin","130021","China","CN",{"type":78,"coordinates":79},"Point",[80,81],125.32278,43.88,{"lat":81,"lon":80},[84,86],{"name":60,"role":61,"phone":85,"phoneExt":20,"email":63},"+86-13074337289",{"name":87,"role":61,"phone":66,"phoneExt":20,"email":67},"Mingyou Zhang, MD",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Mingyou Zhang","Associate Chief Physician, Department of Cardiology","100658025","aspirin-50mg-vs-100mg-combined-with-p2y12-inhibitor-after-pci-100658025",false,"NCT07846462","Aspirin 50mg vs 100mg Combined With P2Y12 Inhibitor After PCI","The Efficacy and Safety of Aspirin 50mg Versus 100mg in Combination With a P2Y12 Inhibitor After Percutaneous Coronary Intervention: A Randomized, Open-label, Active-controlled, Non-inferiority Trial","ASPIRE-LD","Inclusion Criteria:\n\n* Aged 18 to 85 years at the time of screening\n* Diagnosed with acute coronary syndrome (ACS) or chronic coronary syndrome (CCS)\n* Has undergone successful percutaneous coronary intervention (PCI) with stent implantation\n* Planned to receive at least 12 months of dual antiplatelet therapy (DAPT) with aspirin plus a P2Y12 inhibitor after PCI\n* Able to provide written informed consent and comply with study follow-up requirements\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to aspirin, P2Y12 inhibitors, or related excipients\n* High bleeding risk: history of intracranial hemorrhage, gastrointestinal bleeding within 6 months, active bleeding diathesis, or coagulopathy\n* Severe hepatic dysfunction (Child-Pugh class C) or severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n* Ischemic or hemorrhagic stroke within 3 months before enrollment\n* Pregnant or lactating women; women of childbearing potential unwilling to use effective contraception\n* Life expectancy \\\u003C 12 months due to other severe comorbidities such as advanced malignancy\n* Participation in another interventional clinical trial within 30 days before screening\n* Any other condition judged by the investigator to make the patient unsuitable for the study","ALL","18 Years","85 Years",{"count":104,"type":105},2640,"ESTIMATED","INTERVENTIONAL",[108],"NA","This is a randomized, open-label, active-controlled, non-inferiority clinical trial (the ASPIRE-LD trial) conducted in China. It aims to compare the efficacy and safety of low-dose aspirin (50 mg once daily) versus standard-dose aspirin (100 mg once daily), both in combination with a P2Y12 inhibitor, in patients who have successfully undergone percutaneous coronary intervention (PCI) and plan to receive at least 12 months of dual antiplatelet therapy (DAPT).\n\nA total of 2640 eligible patients will be randomly assigned in a 1:1 ratio to receive either 50 mg or 100 mg of enteric-coated aspirin daily, plus a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily, prescribed according to routine clinical practice). All participants will be followed for 12 months after randomization.\n\nThe primary goal is to verify that 50 mg aspirin is non-inferior to the 100 mg standard dose in preventing major adverse cardiac and cerebrovascular events (MACCE: cardiovascular death, non-fatal myocardial infarction, definite\u002Fprobable stent thrombosis, and ischemic stroke) at 12 months post-PCI. If non-inferiority is confirmed, the study will further test whether 50 mg aspirin reduces clinically relevant bleeding events (BARC type 2, 3, or 5) better than the standard dose.\n\nThe study is sponsored by the First Hospital of Jilin University and will be carried out in 10-15 tertiary hospitals across China. Its findings will provide evidence for optimizing aspirin dosing in post-PCI DAPT.",[111,112,113,114],"Coronary Artery Disease","Acute Coronary Syndromes","Chronic Coronary Syndrome","Percutaneous Coronary Intervention",[46,116,117,32,118,119,120],"Dual Antiplatelet Therapy (DAPT)","Percutaneous Coronary Intervention (PCI)","P2Y12 Inhibitor","Major Adverse Cardiac and Cerebrovascular Events","Bleeding","2026-09-29",{"date":123,"type":124},"2026-10-01","ACTUAL",{"date":126,"type":124},"2026-03-01",{"date":128,"type":105},"2029-04-01",{"name":5,"class":6},1]