SWITCH: Apixaban vs Vitamin K in HM3

NCT07471139 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: AAAV9532
• Study Type: interventional
• Target: 460
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Failure; Bleeding; Thrombosis; Artery; LVAD (Left Ventricular Assist Device) Thrombosis; Stroke; Heart Transplant

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (7)

• Non-surgical Major Hemorrhagic Events

  12 months

• Non-surgical Major Thrombotic Events

  12 months

• Survival

  12 months

• Stroke Rates

  12 months

• Pump Thrombosis Rates

  12 months

Other Outcomes (22)

• Patient functional status

  12 months

• Patient QOL

  12 months

• LVAD device speed

  12 months

Study Arms (2)

Warfarin

ACTIVE COMPARATOR

Participants will take warfarin, dose titrated for an INR \>= 1.8

Drug: Warfarin

Apixaban

EXPERIMENTAL

Participants wil take apixaban 5 mg bid

Drug: Apixaban

Interventions

Warfarin DRUG

Warfarin dose titrated for an International Normalized Ratio (INR) \>= 1.8

Also known as: COUMADIN, warfarin sodium

Warfarin

Apixaban DRUG

Apixaban 5 mg bid (twice a day)

Also known as: Eliquis

Apixaban

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Related Publications (2)

• Netuka I, Tucanova Z, Ivak P, Gregor S, Kolesar DM, Marek T, Melenovsky V, Binova J, Dorazilova Z, Hegarova M, Podolec M, Riha H, Connors JM, Mehra MR. A Prospective Randomized Trial of Direct Oral Anticoagulant Therapy With a Fully Magnetically Levitated LVAD: The DOT-HM3 Study. Circulation. 2024 Aug 6;150(6):509-511. doi: 10.1161/CIRCULATIONAHA.124.069726. Epub 2024 Apr 9. No abstract available.

  PMID: 38594972 BACKGROUND

• Shah P, Looby M, Dimond M, Bagchi P, Shah B, Isseh I, Rollins AT, Abdul-Aziz AA, Kennedy J, Tang DG, Klein KM, Casselman S, Vermeulen C, Sheaffer W, Snipes M, Sinha SS, O'Connor CM. Evaluation of the Hemocompatibility of the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices: The DOAC LVAD Study. JACC Heart Fail. 2024 Sep;12(9):1540-1549. doi: 10.1016/j.jchf.2024.04.013. Epub 2024 May 7.

  PMID: 38795110 BACKGROUND

MeSH Terms

Conditions

Thrombosis; Heart Failure; Hemorrhage; Stroke

Interventions

Warfarin; apixaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nir Uriel, MD

  New York Presbyterian / Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilan Richter, MD

CONTACT

3322098345; ir2498@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Seymour, Paul, and Gloria Milstein Professor of Cardiology (in Medicine)

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share