A Phase 3 interventional study of Warfarin and Apixaban in LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure and Bleeding, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Columbia University · Phase 3, Interventional, and Treatment
This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced heart failure who are chronically supported by a HeartMate 3 Left Ventricular Assist Device for 3 months.
Heart failure is a global epidemic, and Left Ventricular Assist Devices (LVADs) - particularly the HeartMate 3 (HM3) - are increasingly used due to their survival benefit over medical therapy. Despite advances, hemocompatibility-related adverse events (HRAEs) like thrombosis and bleeding remain significant causes of morbidity and mortality.
Direct Oral Anticoagulants (DOACs) have shown superiority over warfarin in heart failure patients, with lower rates of embolic and intracranial bleeding. Reduced-dose DOACs also appear to reduce major bleeding without increasing thrombotic risk. However, data on their use in LVAD patients is limited, consisting mainly of case reports, small series, retrospective analyses, and a few small randomized clinical trials.
Some reports suggest apixaban may reduce bleeding in high-risk LVAD patients, though cases of pump thrombosis and stroke have occurred. Early studies comparing DOACs to warfarin in patients with HeartMate II (HMII), HeartWare™ HVAD™ System, and The Abbott HeartMate 3 (HM3) show no significant differences in outcomes, with a trend toward less bleeding with apixaban. Two small randomized clinical trials in HM3 patients (The DOAC LVAD Study and The DOT-HM3 Study) found similar results.
This prospective, randomized, controlled, non-inferiority trial will evaluate the safety and efficacy of apixaban versus vitamin K antagonists in HM3 patients more than 3 months post-implant.
955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.
This study's planned enrollment of 460 is above the median of 83 across 530 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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.
Exclusion Criteria:
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.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Participants will take warfarin, dose titrated for an INR \>= 1.8
Drug: Warfarin
Participants wil take apixaban 5 mg bid
Drug: Apixaban
Survival free of major hemocompatibility related adverse event
Major Hemocompatibility Related Adverse Event: Stroke, Pump Thrombosis, major non surgical Bleeding (moderate or severe), Arterial Peripheral Thromboembolism. Rates will be compared between study groups.
Time frame: 12 months
Non-surgical Major Hemorrhagic Events
Rates will be compared between study groups.
Time frame: 12 months
Non-surgical Major Thrombotic Events
Rates will be compared between study groups.
Time frame: 12 months
Survival
Rates will be compared between study groups.
Time frame: 12 months
Stroke Rates
Rates will be compared between study groups.
Time frame: 12 months
Pump Thrombosis Rates
Rates will be compared between study groups.
Time frame: 12 months
Bleeding Rates
Rates will be compared between study groups.
Time frame: 12 months
Rates of listing for Heart Transplant
Rates will be compared between study groups.
Time frame: 12 months
Patient functional status
Association between anticoagulant regimen and New York Heart Association (NYHA) Functional Classification (FC) will be compared between groups. Scores range I through IV, with higher scores indicating worse outcome.
Time frame: 12 months
Patient QOL
Kansas City Cardiomyopathy Questionnaire (KCCQ) 12 scores will be compared between groups. Scores range 1-100, with higher scores indicating better health status.
Time frame: 12 months
LVAD device speed
LVAD speed (mean, SD) of LVAD will be compared between study groups. Speed ranges 4500-6000 RPM.
Time frame: 12 months
LVAD device flow
LVAD flow (mean, SD) of LVAD will be compared between study groups. Flow ranges 3-6 L/min.
Time frame: 12 months
LVAD device pulsatility index
LVAD pulsatility index (PI) will be compared between study groups. PI ranges 1-4 (no units).
Time frame: 12 months
LVAD device power
LVAD power (mean, SD) will be compared between study groups. Power ranges 3-7 W.
Time frame: 12 months
Right atrial pressure
Right atrial (RA) pressure (mean, SD) will be compared between study groups. RA ranges 0-20 mmHg.
Time frame: 12 months
Right ventricular systolic pressure
Right ventricular (RV) systolic pressure (mean, SD) will be compared between study groups. RV systolic pressure ranges 0-100 mmHg.
Time frame: 12 months
Right ventricular diastolic pressure
Right ventricular (RV) diastolic pressure (mean, SD) will be compared between study groups. RV diastolic pressure ranges 0-50 mmHg.
Time frame: 12 months
Pulmonary artery systolic pressure
Pulmonary artery (PA) systolic pressure (mean, SD) will be compared between study groups. PA systolic pressure ranges 0-100 mmHg.
Time frame: 12 months
Pulmonary artery diastolic pressure
Pulmonary artery (PA) diastolic pressure (mean, SD) will be compared between study groups. PA diastolic pressure ranges 0-50 mmHg.
Time frame: 12 months
Pulmonary artery mean pressure
Pulmonary artery (PA) mean pressure (mean, SD) will be compared between study groups. PA mean pressure ranges 0-50 mmHg.
Time frame: 12 months
Pulmonary capillary wedge pressure
Pulmonary capillary wedge pressure (PCWP, mean, SD) will be compared between study groups. PCWP ranges 0-50 mmHg.
Time frame: 12 months
Cardiac output
Cardiac output (CO, mean, SD) will be compared between study groups. CO ranges 3-10 L/min.
Time frame: 12 months
Invasive hemodynamics
Cardiac index (CI, mean, SD) will be compared between study groups. CI ranges 2.5-4 L/min/m\^2.
Time frame: 12 months
Drive line infection rates
Rate of drive line infections will be compared between study groups.
Time frame: 12 months
VAD coordinator time
Means will be compared between study groups.
Time frame: 12 months
Laboratory monitoring
A quantitative comparison of performed laboratory tests to monitor anticoagulation between groups (counts)
Time frame: 12 months
Days hospitalized
Means will be compared between study groups.
Time frame: 12 months
Caregiver burden
Self assessed caregiver burden will be collected using the validated The Oberst Caregiving Burden Scale (OCBS), and compared between study groups. Scores range 15-75, with higher scores indicating higher levels of caregiving burden (more time spent or greater difficulty).
Time frame: 12 months
Time in therapeutic range in the warfarin sodium group
Means, as well as rates above 70%, will be compared between study groups.
Time frame: 12 months
Apixaban levels in patients incurring adverse event
Time frame: 12 months
Plan to share: No
Started Oct 2026 (actual). Primary completion is estimated for Aug 2029, 34 months after the start.
Of 27 phase 3 interventional studies under Thrombosis, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 57. This study's planned 34 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: start Aug 2026 → Oct 2026 and completion Aug 2029 → Oct 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Apixaban