SWITCH: Apixaban vs Vitamin K in HM3

March 11, 2026 updated by: Nir Uriel, Columbia University

The SWITCH Trial: A Randomized Controlled Study of Apixaban Versus Vitamin K Antagonists in Patients With HeartMate 3 Left Ventricular Assist Devices

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

460

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants will have HeartMate3 LVAD implanted > 3 months before enrollment
  • ≥ 18 years old
  • Treated with WARFARIN SODIUM
  • Participant must provide written informed consent prior to any clinical investigation related procedure
  • In female participants of childbearing capability, not currently pregnant and on appropriate contraception

Exclusion Criteria:

  • Participation in any other clinical investigation(s) involving a Mechanical Circulatory Support (MCS) device, or interventional investigation(s) likely to confound study results or affect study outcome
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
  • Known allergy to Apixaban
  • Bridge to transplant
  • Severe renal dysfunction Estimated Glomerular Filtration Rate (eGFR) <20
  • History of major bleeding event with subsequent reduction of INR goal to < 1.8
  • Apixaban dose reduction criteria (Age ≥80 years, weight ≤60 kg, creatinine ≥1.5 mg/dL)
  • Aortic root thrombus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Warfarin
Participants will take warfarin, dose titrated for an INR >= 1.8
Drug: Warfarin
Warfarin dose titrated for an International Normalized Ratio (INR) >= 1.8
Other Names:
  • COUMADIN
  • warfarin sodium
Experimental: Apixaban
Participants wil take apixaban 5 mg bid
Drug: Apixaban
Apixaban 5 mg bid (twice a day)
Other Names:
  • Eliquis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival free of major hemocompatibility related adverse event
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-surgical Major Hemorrhagic Events
Time Frame: 12 months
Rates will be compared between study groups.
12 months
Non-surgical Major Thrombotic Events
Time Frame: 12 months
Rates will be compared between study groups.
12 months
Survival
Time Frame: 12 months
Rates will be compared between study groups.
12 months
Stroke Rates
Time Frame: 12 months
Rates will be compared between study groups.
12 months
Pump Thrombosis Rates
Time Frame: 12 months
Rates will be compared between study groups.
12 months
Bleeding Rates
Time Frame: 12 months
Rates will be compared between study groups.
12 months
Rates of listing for Heart Transplant
Time Frame: 12 months
Rates will be compared between study groups.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient functional status
Time Frame: 12 months
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.
12 months
Patient QOL
Time Frame: 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) 12 scores will be compared between groups. Scores range 1-100, with higher scores indicating better health status.
12 months
LVAD device speed
Time Frame: 12 months
LVAD speed (mean, SD) of LVAD will be compared between study groups. Speed ranges 4500-6000 RPM.
12 months
LVAD device flow
Time Frame: 12 months
LVAD flow (mean, SD) of LVAD will be compared between study groups. Flow ranges 3-6 L/min.
12 months
LVAD device pulsatility index
Time Frame: 12 months
LVAD pulsatility index (PI) will be compared between study groups. PI ranges 1-4 (no units).
12 months
LVAD device power
Time Frame: 12 months
LVAD power (mean, SD) will be compared between study groups. Power ranges 3-7 W.
12 months
Right atrial pressure
Time Frame: 12 months
Right atrial (RA) pressure (mean, SD) will be compared between study groups. RA ranges 0-20 mmHg.
12 months
Right ventricular systolic pressure
Time Frame: 12 months
Right ventricular (RV) systolic pressure (mean, SD) will be compared between study groups. RV systolic pressure ranges 0-100 mmHg.
12 months
Right ventricular diastolic pressure
Time Frame: 12 months
Right ventricular (RV) diastolic pressure (mean, SD) will be compared between study groups. RV diastolic pressure ranges 0-50 mmHg.
12 months
Pulmonary artery systolic pressure
Time Frame: 12 months
Pulmonary artery (PA) systolic pressure (mean, SD) will be compared between study groups. PA systolic pressure ranges 0-100 mmHg.
12 months
Pulmonary artery diastolic pressure
Time Frame: 12 months
Pulmonary artery (PA) diastolic pressure (mean, SD) will be compared between study groups. PA diastolic pressure ranges 0-50 mmHg.
12 months
Pulmonary artery mean pressure
Time Frame: 12 months
Pulmonary artery (PA) mean pressure (mean, SD) will be compared between study groups. PA mean pressure ranges 0-50 mmHg.
12 months
Pulmonary capillary wedge pressure
Time Frame: 12 months
Pulmonary capillary wedge pressure (PCWP, mean, SD) will be compared between study groups. PCWP ranges 0-50 mmHg.
12 months
Cardiac output
Time Frame: 12 months
Cardiac output (CO, mean, SD) will be compared between study groups. CO ranges 3-10 L/min.
12 months
Invasive hemodynamics
Time Frame: 12 months
Cardiac index (CI, mean, SD) will be compared between study groups. CI ranges 2.5-4 L/min/m^2.
12 months
Drive line infection rates
Time Frame: 12 months
Rate of drive line infections will be compared between study groups.
12 months
VAD coordinator time
Time Frame: 12 months
Means will be compared between study groups.
12 months
Laboratory monitoring
Time Frame: 12 months
A quantitative comparison of performed laboratory tests to monitor anticoagulation between groups (counts)
12 months
Days hospitalized
Time Frame: 12 months
Means will be compared between study groups.
12 months
Caregiver burden
Time Frame: 12 months
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).
12 months
Time in therapeutic range in the warfarin sodium group
Time Frame: 12 months
Means, as well as rates above 70%, will be compared between study groups.
12 months
Apixaban levels in patients incurring adverse event
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Nir Uriel, MD, New York Presbyterian / Columbia University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAV9532

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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