[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638631":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":58,"centralContacts":59,"locations":69,"responsibleParty":101,"collaborators":58,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":58,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":58,"enrollmentInfo":113,"targetDuration":58,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":128,"overallStatus":71,"whyStopped":58,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"TARGET","EXPERIMENTAL","Participants receive postoperative antiplatelet therapy consistent with standard of care, with regimen adjustments guided by serial TEG-PM (Thromboelastography with Platelet Mapping) assessments. The goal is to maintain platelet inhibition within a therapeutic window of 29-86%. If platelet inhibition falls outside this range at any timepoint, the antiplatelet regimen is escalated or de-escalated per a prespecified algorithm. TEG-PM testing occurs at 1 week, 1, 3, 6, 9, and 12 months postoperatively, with repeat testing 7 days after any medication change.",[13,14,15,16,17],"Drug: Aspirin","Drug: Clopidogrel","Drug: Ticagrelor","Drug: Rivaroxaban","Device: Thromboelastography with Platelet Mapping",{"label":19,"type":20,"description":21,"interventionNames":22},"Standard of Care (SOC)","ACTIVE_COMPARATOR","Participants receive standard postoperative antiplatelet therapy per the treating surgeon's preference (dual antiplatelet therapy or aspirin combined with low-dose rivaroxaban) for the 12-month follow-up period. TEG-PM testing is performed at all scheduled timepoints for data collection purposes only; no medication adjustments are made based on results.",[13,14,15,16,17],[24,31,37,43,49],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Aspirin","Aspirin is an oral antiplatelet agent that inhibits cyclooxygenase-mediated thromboxane A2 production, reducing platelet aggregation. It serves as the foundational antiplatelet agent in both study arms following lower extremity endovascular revascularization.",[19,9],[30],"Acetylsalicylic Acid; ASA",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Clopidogrel","Clopidogrel is an oral P2Y12 platelet inhibitor used as part of postoperative antiplatelet therapy following lower extremity endovascular revascularization. In the SOC arm, it is administered as part of a fixed dual antiplatelet regimen. In the TARGET arm, it serves as an initial antiplatelet agent, with continuation or substitution determined by TEG-PM platelet inhibition results and VerifyNow P2Y12 resistance testing. If clopidogrel resistance is identified or platelet inhibition remains below the 29% threshold, clopidogrel may be replaced with ticagrelor per the study algorithm.",[19,9],[36],"Plavix",{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Ticagrelor","Ticagrelor is an oral, reversible P2Y12 platelet inhibitor. Unlike clopidogrel, ticagrelor demonstrates minimal resistance and more consistent platelet inhibition, making it a preferred escalation agent.",[19,9],[42],"Brilinta",{"type":25,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Rivaroxaban","Rivaroxaban is an oral factor Xa inhibitor used in both study arms. In the SOC arm, low-dose rivaroxaban combined with aspirin represents one of two standard postoperative regimens, administered per surgeon preference. In the TARGET arm, rivaroxaban may be initiated or substituted based on TEG-PM platelet inhibition results and clopidogrel resistance testing findings. Full-dose rivaroxaban is reserved for patients who remain persistently hypercoagulable despite stepwise antiplatelet escalation, prior to hematology referral.",[19,9],[48],"Xarelto",{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DEVICE","Thromboelastography with Platelet Mapping","Whole-blood, viscoelastic point-of-care assay used to assess real-time coagulation status and platelet function.",[19,9],[55,56,57],"TEG-PM","TEG 6s","Haemonetics TEG 6s Hemostasis Analyzer",null,[60,65],{"name":61,"role":62,"phone":63,"phoneExt":58,"email":64},"Anahita Dua, MBCHB, MBA, MSC","CONTACT","262-565-8247","adua1@mgh.harvard.edu",{"name":66,"role":62,"phone":67,"phoneExt":58,"email":68},"Swechha Bhatt, MBBS","339-242-0052","sbhatt12@mgh.harvard.edu",[70,87],{"facility":5,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-71.05977,42.35843,{"lat":81,"lon":80},[84,86],{"name":61,"role":62,"phone":85,"phoneExt":58,"email":64},"+12625658247",{"name":66,"role":62,"phone":67,"phoneExt":58,"email":68},{"facility":88,"status":71,"city":89,"state":73,"zip":90,"country":75,"countryCode":76,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Salem Hospital (Mass General Brigham)","Salem","01970",{"type":78,"coordinates":92},[93,94],-70.89552,42.51977,{"lat":94,"lon":93},[97],{"name":98,"role":62,"phone":99,"phoneExt":58,"email":100},"Shaidah Deghan, MD, MSC","781-779-9219","sdeghan@mgh.harvard.edu",{"type":102,"investigatorFullName":61,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"PRINCIPAL_INVESTIGATOR","Associate Professor of Surgery, Harvard Medical School","100638631","personalizing-thromboprophylaxis-for-patients-with-peripheral-artery-disease-100638631",false,"NCT07613840","Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease","Personalizing Post Surgical Thromboprophylaxis for Patients With Peripheral Artery Disease","Inclusion Criteria:\n\n* Patients with a named arterial extremity injury or named vessel revascularization for atherosclerosis requiring open and\u002For closed revascularization.\n* Patients at the age of 18 or older\n\nExclusion Criteria:\n\n* Patients who are younger than 18 years old\n* Known pregnancy (females of childbearing potential will have a pregnancy test prior to surgery as per standard of care)\n* Prisoners, defined as those who have been directly admitted from a correctional facility.\n* No atherosclerosis\n* Subject has active stomach ulcers\n* Subject has severe hepatic impairment\n* Subject has a recent history of intracranial hemorrhage. If the patient has a history of cerebral hemorrhage with no new central nervous system disease of \\>1 year, the study team will consult with the","ALL","18 Years",{"count":114,"type":115},484,"ESTIMATED","INTERVENTIONAL",[118],"NA","The goal of this clinical trial is to determine whether a personalised blood clot prevention plan is more effective than standard treatment in adults with peripheral artery disease (PAD) who have undergone a procedure to restore blood flow to their legs.\n\nThe main questions it aims to answer are:\n\n* Does the personalized plan lower the rate of blood clots in the treated leg one year after the procedure?\n* Does the personalized plan lower rates of amputation, repeat procedures, bleeding, and death compared to standard treatment?\n\nResearchers will compare the personalized TARGET plan which uses a blood test to tailor each person's blood clot prevention medication to the standard treatment to see if the personalized approach works better.\n\nParticipants will:\n\n* Be randomly assigned to either the personalized TARGET plan or standard treatment after their procedure\n* Have blood tests at 1 week and at 1, 3, 6, 9, and 12 months after their procedure\n* Have medications adjusted based on blood test results if assigned to the TARGET group",[121,122,123,124,125,126,127],"Peripheral Arterial Disease (PAD)","Amputation","Thrombosis","Thrombosis (Stent Thrombosis)","Platelet Aggregation Inhibitors","Thromboelastography (TEG)","PRU(Platelet Reactivity Unit)",[129,130,131,132,133,134],"Peripheral Artery Disease Thromboprophylaxis","Personalizing Blood Thinners","Clopidogrel Resistance","Thromboelastography with Platelet Mapping (TEG-PM)","Graft\u002F Stent Thrombosis","Platelet Inhibition","2026-05-21",{"date":137,"type":138},"2026-05-29","ACTUAL",{"date":140,"type":138},"2025-04-29",{"date":142,"type":115},"2027-06-30",{"name":5,"class":6},2]