A Phase 3 interventional study of Warfarin and Apixaban in LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure and Bleeding, sponsored by Columbia University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
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.
Exclusion Criteria:
Participants will take warfarin, dose titrated for an INR \>= 1.8
Drug: Warfarin
Participants wil take apixaban 5 mg bid
Drug: Apixaban
Warfarin dose titrated for an International Normalized Ratio (INR) \>= 1.8
Also known as: COUMADIN, warfarin sodium
Apixaban 5 mg bid (twice a day)
Also known as: Eliquis
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
No study locations are listed for this record.
Plan to share: No
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Columbia University