A Phase 4 interventional study of Warfarin (low-intensity anticoagulation) and Warfarin (standard anticoagulation) in Advanced Heart Failure, Left Ventricular Assist Devices and Anticoagulation Treatment, sponsored by Asan Medical Center. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Asan Medical Center · Phase 4, Interventional, and Prevention
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).
Despite 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.
The 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.
The 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.
The 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.
The 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.
This 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.
338 studies on the registry are indexed under Gastrointestinal Hemorrhage; 77 are open to participants now.
This study's planned enrollment of 94 is close to the median of 98 across 210 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Asan Medical Center is the lead sponsor of 578 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults aged ≥19 years who have successfully undergone implantation of a HeartMate 3 LVAD.
Patients who are at least 30 days post-implantation of HeartMate 3 LVAD.
Patients who have maintained stable anticoagulation therapy with standard (2.0-3.0) for at least 30 days post-LVAD implantation.
Patients or their legal representatives who provide documented and agree to the study protocol and follow-up schedule.
Exclusion Criteria:
Patients implanted with any mechanical assist device other than HeartMate 3 LVAD (e.g., other LVAD models, RVAD, BiVAD).
Patients with a stroke or (TIA) within the past 6 months.
Patients with a history of hemorrhagic stroke.
Patients who experienced major bleeding events within the past 6 months (based on INTERMACS major bleeding criteria).
Patients with uncontrolled severe hypertension (systolic ≥180 mmHg or diastolic ≥110 mmHg).
Patients 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.
Patients with severe renal dysfunction (estimated \<15 mL/min) or patients undergoing dialysis.
Patients with severe liver dysfunction causing coagulation abnormalities or those classified as class B or C.
Patients with active bleeding or ongoing hemorrhagic conditions.
Patients with a high bleeding risk due to:
Gastrointestinal bleeding or ulcers within the past 6 months.
Surgery involving the brain, spine, or eyes within the past 6 months.
Major central nervous system, ophthalmologic, or major open surgical procedures within the past 6 months.
Presence or suspicion of esophageal varices.
Arteriovenous malformation or vascular aneurysm.
Patients who have received thrombolytic therapy for bleeding or thromboembolism within the past 30 days.
Patients 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.
Patients with persistent anemia ( \<8 g/dL) or thrombocytopenia ( count \<50,000/µL) within the past 6 months.
Patients currently experiencing infective endocarditis.
Patients with a history of severe allergy or to warfarin or other anticoagulants used in this study.
Pregnant or lactating women, or women planning pregnancy during the study period.
Patients with severe terminal illness with a of less than 12 months.
Patients with alcohol dependence or severe psychiatric conditions hindering study participation.
Patients unwilling or unable to adhere to the procedures or evaluations required by the study protocol.
Patients currently participating in another randomized drug or medical device clinical trial who have not yet completed the primary endpoint assessment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention: Drug: Warfarin (INR 1.5-2.0)
Drug: Warfarin (low-intensity anticoagulation)
Intervention: Drug: Warfarin (INR 2.0-3.0)
Drug: Warfarin (standard anticoagulation)
Low-intensity INR group (Experimental): Participants will receive anticoagulation therapy with warfarin, aiming for a reduced INR range of 1.5-2.0, which is lower than the current standard recommendation. Warfarin dosing will be regularly adjusted based on INR monitoring throughout the 6-month study period.
Standard INR group (Active Comparator): Participants will receive anticoagulation therapy with warfarin, maintaining an INR within the standard therapeutic range of 2.0-3.0. Warfarin dosing adjustments will be made regularly according to standard clinical practice and INR monitoring throughout the 6-month study period.
Incidence of composite hemocompatibility-related events
The primary outcome is defined as a composite of hemocompatibility-related events including major bleeding (INTERMACS major bleeding criteria), stroke (ischemic or hemorrhagic), and pump thrombosis occurring within 6 months post-randomization. Events will be centrally adjudicated based on standardized INTERMACS definitions.
Time frame: Within 6 months after randomization
All-cause mortality
Incidence of death due to any cause.
Time frame: Within 6 months after randomization
Cardiac death
Incidence of death directly attributed to cardiac causes, including heart failure, myocardial infarction, or sudden cardiac death.
Time frame: Within 6 months after randomization
LVAD pump thrombosis
Incidence of pump thrombosis as defined by INTERMACS criteria, requiring intervention, replacement, or explantation of the LVAD.
Time frame: Within 6 months after randomization
LVAD-related thromboembolism
Incidence of thromboembolic events directly related to LVAD, including embolic strokes or systemic embolisms.
Time frame: Within 6 months after randomization
Transient ischemic attack (TIA)
Incidence of transient neurologic deficits lasting less than 24 hours without evidence of acute infarction.
Time frame: Within 6 months after randomization
Stroke
Incidence of ischemic or hemorrhagic stroke with clinical neurologic deficits lasting ≥24 hours, as defined by NeuroARC criteria.
Time frame: Within 6 months after randomization
Systemic embolism
Incidence of acute systemic embolism affecting major organs or limbs, confirmed by imaging or surgical findings.
Time frame: Within 6 months after randomization
Myocardial infarction
Incidence of myocardial infarction diagnosed by typical symptoms, ECG changes, and elevation of cardiac biomarkers.
Time frame: Within 6 months after randomization
Major bleeding event
Incidence of major bleeding as defined by INTERMACS major bleeding criteria, including events requiring transfusion or intervention.
Time frame: Within 6 months after randomization
Composite (cardiac death, pump thrombosis, thromboembolism)
Combined incidence of cardiac death, LVAD pump thrombosis, and LVAD-related thromboembolic events.
Time frame: Within 6 months after randomization
Composite (cardiac death, thrombosis, stroke, embolism, MI)
Combined incidence of cardiac death, LVAD pump thrombosis, stroke, systemic embolism, and myocardial infarction.
Time frame: Within 6 months after randomization
Composite (stroke, embolism, TIA, MI)
Combined incidence of stroke, systemic embolism, transient ischemic attack, and myocardial infarction.
Time frame: Within 6 months after randomization
Composite (death, stroke, embolism, TIA, MI)
Combined incidence of all-cause mortality, stroke, systemic embolism, transient ischemic attack, and myocardial infarction.
Time frame: Within 6 months after randomization
LVAD-related readmission
Incidence and frequency of hospital readmissions directly related to LVAD management or complications.
Time frame: Within 6 months after randomization
LVAD-related reoperation
Incidence and frequency of surgical reoperations directly related to LVAD complications or device malfunction.
Time frame: Within 6 months after randomization
Time in therapeutic range (TTR)
Proportion of time patients' INR values remain within the predefined therapeutic target range.
Time frame: Within 6 months after randomization
Out-of-range INR proportion
Proportion of INR measurements falling outside the predefined therapeutic target range.
Time frame: Within 6 months after randomization
Warfarin dose adjustments
Number of warfarin dose adjustments required to maintain target INR range.
Time frame: Within 6 months after randomization
Plan to share: Undecided
Start is estimated for Oct 2025; primary completion for Oct 2028, 36 months later.
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Studies of the drug tested here: Warfarin