SWITCH: Apixabano vs Vitamina K em HM3
O Estudo SWITCH: Um Estudo Randomizado Controlado de Apixabano versus Antagonistas da Vitamina K em Pacientes com Dispositivos de Assistência Ventricular Esquerda HeartMate 3
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Ilan Richter, MD
- Número de telefone: 3322098345
- E-mail: ir2498@cumc.columbia.edu
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10032
- Recrutamento
- Columbia University Irving Medical Center
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Contato:
- Ilan Richter, MD
- Número de telefone: 212-305-7600
- E-mail: ir2498@cumc.columbia.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Warfarin
Participants will take warfarin, dose titrated for an INR >= 1.8 |
Warfarin dose titrated for an International Normalized Ratio (INR) >= 1.8
Outros nomes:
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Experimental: Apixaban
Participants wil take apixaban 5 mg bid |
Apixaban 5 mg bid (twice a day)
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Survival free of major hemocompatibility related adverse event
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Non-surgical Major Hemorrhagic Events
Prazo: 12 months
|
Rates will be compared between study groups. |
12 months
|
|
Non-surgical Major Thrombotic Events
Prazo: 12 months
|
Rates will be compared between study groups. |
12 months
|
|
Survival
Prazo: 12 months
|
Rates will be compared between study groups. |
12 months
|
|
Stroke Rates
Prazo: 12 months
|
Rates will be compared between study groups. |
12 months
|
|
Pump Thrombosis Rates
Prazo: 12 months
|
Rates will be compared between study groups. |
12 months
|
|
Bleeding Rates
Prazo: 12 months
|
Rates will be compared between study groups. |
12 months
|
|
Rates of listing for Heart Transplant
Prazo: 12 months
|
Rates will be compared between study groups. |
12 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Níveis de apixabano em doentes com eventos adversos
Prazo: 12 meses
|
12 meses
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|
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Patient functional status
Prazo: 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
Prazo: 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
Prazo: 12 months
|
LVAD speed (mean, SD) of LVAD will be compared between study groups. Speed ranges 4500-6000 RPM. |
12 months
|
|
LVAD device flow
Prazo: 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
Prazo: 12 months
|
LVAD pulsatility index (PI) will be compared between study groups. PI ranges 1-4 (no units). |
12 months
|
|
LVAD device power
Prazo: 12 months
|
LVAD power (mean, SD) will be compared between study groups. Power ranges 3-7 W. |
12 months
|
|
Right atrial pressure
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 12 months
|
Pulmonary capillary wedge pressure (PCWP, mean, SD) will be compared between study groups. PCWP ranges 0-50 mmHg. |
12 months
|
|
Cardiac output
Prazo: 12 months
|
Cardiac output (CO, mean, SD) will be compared between study groups. CO ranges 3-10 L/min. |
12 months
|
|
Invasive hemodynamics
Prazo: 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
Prazo: 12 months
|
Rate of drive line infections will be compared between study groups. |
12 months
|
|
VAD coordinator time
Prazo: 12 months
|
Means will be compared between study groups. |
12 months
|
|
Laboratory monitoring
Prazo: 12 months
|
A quantitative comparison of performed laboratory tests to monitor anticoagulation between groups (counts) |
12 months
|
|
Days hospitalized
Prazo: 12 months
|
Means will be compared between study groups. |
12 months
|
|
Caregiver burden
Prazo: 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
Prazo: 12 months
|
Means, as well as rates above 70%, will be compared between study groups. |
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nir Uriel, MD, New York Presbyterian / Columbia University Medical Center
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Doenças cardíacas
- Embolia e Trombose
- Condições Patológicas, Sinais e Sintomas
- Derrame
- Insuficiência cardíaca
- Trombose
- Hemorragia
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Pyrans
- Coumarins
- Benzopyrans
- 4-hidroxicoumarinas
- Varfarina
- apixaban
Outros números de identificação do estudo
- AAAV9532
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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