[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thrombotic-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thrombotic-complications":31},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":5},"100599172","phase-4-trial-of-low-intensity-anticoagulation-to-reduce-gi-or-other-bleeding-complications-with-equivalent-therapeutic-efficacy-in-heartmate-3-lvad-patients-100599172",false,"NCT07081035","Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients","A Prospective Study Evaluating the Safety and Efficacy of Lower-Intensity INR Target (1.5-2.0) Versus Standard INR Target (2.0-3.0) in Patients Implanted With a HeartMate 3 Left Ventricular Assist Device (LVAD)","TARGET","Inclusion Criteria:\n\n* Patients who meet all of the following criteria will be eligible for randomization:\n\nAdults aged ≥19 years who have successfully undergone implantation of a HeartMate 3 LVAD.\n\nPatients who are at least 30 days post-implantation of HeartMate 3 LVAD.\n\nPatients who have maintained stable anticoagulation therapy with standard INR (2.0-3.0) for at least 30 days post-LVAD implantation.\n\nPatients or their legal representatives who provide documented informed consent and agree to the study protocol and follow-up schedule.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded:\n\nPatients implanted with any mechanical assist device other than HeartMate 3 LVAD (e.g., other LVAD models, RVAD, BiVAD).\n\nPatients with a clinically significant stroke or transient ischemic attack (TIA) within the past 6 months.\n\nPatients with a history of hemorrhagic stroke.\n\nPatients who experienced major bleeding events within the past 6 months (based on INTERMACS major bleeding criteria).\n\nPatients with uncontrolled severe hypertension (systolic ≥180 mmHg or diastolic ≥110 mmHg).\n\nPatients requiring active treatment or surgical intervention for acute LVAD-related thrombosis or hemodynamic instability, or patients who underwent LVAD-related reoperation within the past 30 days.\n\nPatients with severe renal dysfunction (estimated Glomerular Filtration Rate \\\u003C15 mL\u002Fmin) or patients undergoing dialysis.\n\nPatients with severe liver dysfunction causing coagulation abnormalities or those classified as Child-Pugh class B or C.\n\nPatients with active bleeding or ongoing hemorrhagic conditions.\n\nPatients with a high bleeding risk due to:\n\nGastrointestinal bleeding or ulcers within the past 6 months.\n\nSurgery involving the brain, spine, or eyes within the past 6 months.\n\nMajor central nervous system, ophthalmologic, or major open surgical procedures within the past 6 months.\n\nPresence or suspicion of esophageal varices.\n\nArteriovenous malformation or vascular aneurysm.\n\nPatients who have received thrombolytic therapy for bleeding or thromboembolism within the past 30 days.\n\nPatients receiving long-term concurrent treatment with other anticoagulants (low molecular weight heparin, NOAC, Fondaparinux, etc.). However, temporary administration for warfarin bridging or heparin use for central venous or arterial catheter maintenance is permitted.\n\nPatients with persistent anemia (hemoglobin \\\u003C8 g\u002FdL) or thrombocytopenia (platelet count \\\u003C50,000\u002FµL) within the past 6 months.\n\nPatients currently experiencing infective endocarditis.\n\nPatients with a history of severe allergy or hypersensitivity to warfarin or other anticoagulants used in this study.\n\nPregnant or lactating women, or women planning pregnancy during the study period.\n\nPatients with severe terminal illness with a life expectancy of less than 12 months.\n\nPatients with alcohol dependence or severe psychiatric conditions hindering study participation.\n\nPatients unwilling or unable to adhere to the procedures or evaluations required by the study protocol.\n\nPatients currently participating in another randomized drug or medical device clinical trial who have not yet completed the primary endpoint assessment.","ALL","19 Years",{"count":20,"type":21},94,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The TARGET trial is a prospective, single-center, randomized, open-label, active-controlled inequality clinical trial designed to evaluate the safety and efficacy of low-intensity anticoagulation therapy (target INR 1.5-2.0) compared to standard anticoagulation therapy (target INR 2.0-3.0) in patients receiving a HeartMate 3 Left Ventricular Assist Device (LVAD).\n\nDespite the demonstrated effectiveness of HeartMate 3 LVAD in reducing thromboembolic complications, standard anticoagulation treatment guidelines recommend maintaining an INR between 2.0 and 3.0, which can lead to a substantial risk of bleeding, especially gastrointestinal (GI) bleeding. Preliminary studies, such as MAGENTUM 1, have indicated potential safety and reduced bleeding events at lower INR targets (1.5-1.9). However, robust evidence through randomized controlled trials is still required.\n\nThe primary objective of the TARGET trial is to determine if low-intensity anticoagulation therapy significantly reduces the incidence of major bleeding and thrombotic events compared to standard therapy within 6 months post-randomization. Secondary objectives include evaluating the safety and hematological complications associated with low-intensity anticoagulation.\n\nThe study will enroll adult patients aged ≥19 years who have been stably maintained on standard INR therapy (2.0-3.0) for at least 30 days post-HeartMate 3 LVAD implantation. Participants will be randomized in a 1:1 ratio into two groups: the low-intensity INR group (target INR 1.5-2.0) and the standard INR group (target INR 2.0-3.0). Randomization will be stratified based on the presence of atrial fibrillation.\n\nThe primary endpoint is a composite of hemocompatibility-related events, including major bleeding, stroke, and pump thrombosis, occurring within 6 months after randomization, as defined by INTERMACS criteria. Secondary endpoints encompass clinical outcomes such as all-cause mortality, cardiac death, LVAD-related thromboembolic events, stroke, systemic embolism, myocardial infarction, major bleeding incidents, and the rate and number of LVAD-related hospital readmissions and reoperations. Additionally, INR management outcomes, including time in therapeutic range (TTR) and frequency of warfarin dose adjustments, will be assessed.\n\nThe trial duration is approximately 36 months, including a 24-month enrollment period, a 6-month follow-up period for each participant, and time allocated for data analysis and reporting. Safety will be rigorously monitored by a Data Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC), ensuring participant safety and data integrity throughout the study.\n\nThis trial aims to provide critical insights that could optimize anticoagulation strategies in LVAD patients, potentially improving patient safety by reducing bleeding risks without compromising thrombotic event protection.",[27,28,29,30,31],"Advanced Heart Failure","Left Ventricular Assist Devices","Anticoagulation Treatment","Bleeding Complications","Thrombotic Complications",[33,34,27,35,36,37,38,39,40,41,42,43,44,45,46],"HeartMate 3 LVAD","Left Ventricular Assist Device","Anticoagulation","Warfarin","International Normalized Ratio (INR)","Low-intensity Anticoagulation","Major Bleeding","Gastrointestinal Bleeding","Pump Thrombosis","Stroke","Thromboembolism","Hemocompatibility","Randomized Controlled Trial","Safety and Efficacy","NOT_YET_RECRUITING","2025-07-15",{"date":50,"type":51},"2025-07-23","ACTUAL",{"date":53,"type":21},"2025-10",{"date":55,"type":21},"2029-01",{"name":57,"class":58},"Asan Medical Center","OTHER"]