SWITCH: Apixaban vs Vitamin K in HM3
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Warfarin, Apixaban.
- Who it may be relevant to
- Registry conditions: LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure, Bleeding, Thrombosis; Artery. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The SWITCH Trial: A Randomized Controlled Study of Apixaban Versus Vitamin K Antagonists in Patients With HeartMate 3 Left Ventricular Assist Devices
Overview
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.
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.
Interventions
- Drug Warfarin
Warfarin dose titrated for an International Normalized Ratio (INR) \>= 1.8 - Drug Apixaban
Apixaban 5 mg bid (twice a day)
Primary outcome measures
- Survival free of major hemocompatibility related adverse event [Time frame: 12 months]
Secondary outcome measures (7)
- Non-surgical Major Hemorrhagic Events [Time frame: 12 months]
- Non-surgical Major Thrombotic Events [Time frame: 12 months]
- Survival [Time frame: 12 months]
- Stroke Rates [Time frame: 12 months]
- Pump Thrombosis Rates [Time frame: 12 months]
- Bleeding Rates [Time frame: 12 months]
- Rates of listing for Heart Transplant [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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 20 PMID 38795110
Identifiers
NCT: NCT07471139 · AAAV9532