[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594876":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":43,"locations":52,"responsibleParty":70,"collaborators":30,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":30,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":30,"enrollmentInfo":81,"targetDuration":30,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":55,"whyStopped":30,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Dual risk - Clopidogrel-based DAPT","EXPERIMENTAL","Patients deemed at high risk for both bleeding and ischemic risk randomized to continue clopdiogrel-based DAPT. High bleeding riks will be defined according to the Academic Research Consortium definition, while high ischemic risk will be defined as those patients with an ABCD-GENE score of 10 or higher.",[13],"Drug: Clopidogrel",{"label":15,"type":10,"description":16,"interventionNames":17},"Dual risk - Low-dose prasugrel-based DAPT","Patients deemed at high risk for both bleeding and ischemic risk randomized to receive low-dose prasugrel-based DAPT. High bleeding riks will be defined according to the Academic Research Consortium definition, while high ischemic risk will be defined as those patients with an ABCD-GENE score of 10 or higher.",[18],"Drug: Prasugrel",{"label":20,"type":21,"description":22,"interventionNames":23},"Control","ACTIVE_COMPARATOR","Patients deemed at high risk for both bleeding but not at high risk for ischemic events being actively treated with clopidogrel-based DAPT as per standard of care. High bleeding riks will be defined according to the Academic Research Consortium definition.",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Prasugrel","Prasugrel 5 mg od for 30 ± 5 days",[15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Clopidogrel","Clopidogrel 75 mg od for 30 ± 5 days",[20,9],[36,40],{"name":37,"affiliation":38,"role":39},"Dominick J Angiolillo, MD, PhD","University of Florida College of Medicine - Jacksonville","STUDY_CHAIR",{"name":41,"affiliation":38,"role":42},"Luis Ortega-Paz, MD, PhD","PRINCIPAL_INVESTIGATOR",[44,48],{"name":41,"role":45,"phone":46,"phoneExt":30,"email":47},"CONTACT","904-244 2060","Luis.Ortega@jax.ufl.edu",{"name":49,"role":45,"phone":50,"phoneExt":30,"email":51},"Andrea Burton, MPH, CCRP","904-244-5617","Andrea.Burton@jax.ufl.edu",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"University of Florida Health","RECRUITING","Jacksonville","Florida","32209","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-81.65565,30.33218,{"lat":65,"lon":64},[68],{"name":41,"role":45,"phone":69,"phoneExt":30,"email":47},"904-244-2060",{"type":71,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100594876","phase-4-dual-antiplatelet-therapy-escalation-from-standard-dose-clopidogrel-to-low-dose-prasugrel-in-patients-with-high-bleeding-and-ischemic-risk-undergoing-pci-a-prospective-randomized-pharmacodynamic-study-tailor-bleed-2-100594876",false,"NCT07025148","Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)","Switching From Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention (TAILOR-BLEED-2)","Inclusion Criteria:\n\n* Patients with high bleeding risk (defined according to the ARC-HBR criteria) who have undergone PCI and are on maintenance treatment with DAPT, consisting of low-dose aspirin (81mg qd) with clopidogrel (75 mg qd) as part of standard of care for at least 30 days.\n* Age ≥18 years.\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Prior cerebrovascular event.\n* PCI within 30 days.\n* Hemodynamic instability.\n* On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis).\n* Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel.\n* Known hematologic malignancies or thrombocytopenia (platelet count \\\u003C80x106\u002FmL).\n* Known hemoglobinopathies or anemia (hemoglobin \\\u003C9 g\u002FdL)\n* Pregnant and breastfeeding women \\[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\\].","ALL","18 Years",{"count":82,"type":83},40,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the HBR-ARC criteria and HIR defined as ABCD-GENE score ≥10) following PCI. We hypothesize that in patients at dual-risk, switching from standard-dose clopidogrel to low-dose prasugrel will be superior to continuing standard-dose clopidogrel in terms of platelet reactivity.",[89,90],"Coronary Arterial Disease (CAD)","Percutaneous Coronary Intervention (PCI)",[92,93,94],"Coronary artery disease","Dual antiplatelet therapy","High bleeding risk","2025-10-31",{"date":97,"type":98},"2025-11-04","ACTUAL",{"date":100,"type":98},"2025-10-01",{"date":102,"type":83},"2027-11-01",{"name":5,"class":6},1]