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- Ensaio Clínico NCT07644247
STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump (STAR)
A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump (STAR Trial)
Visão geral do estudo
Status
Condições
- Derrame
- Trombose
- Sangramento
- Aspirina
- Terapia Antitrombótica
- Sangramento gastrointestinal relacionado a LVAD
- Terapia Antiplaquetária
- LVAD
- Dispositivo de Assistência Ventricular
- Trombose LVAD (Dispositivo de Assistência Ventricular Esquerda)
- LVAD (dispositivo de assistência ventricular esquerda)
- Evento Adverso Relacionado com Hemocompatibilidade
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Kai Chen, Dr
- Número de telefone: 13269333241
- E-mail: ck_2003@126.com
Estude backup de contato
- Nome: Zelin Yin
- Número de telefone: 13321153733
- E-mail: zelin_0823@163.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
-
Study participants must meet all the following criteria:
- Age ≥18 years old;
- Implanted with the CH-VAD pump for advanced heart failure, and the CH-VAD pump is the first implanted left ventricular assist device;
- Able to understand the study purpose, voluntarily participate and sign the informed consent form, and willing to comply with the study procedures and follow-up requirements.
Exclusion Criteria:
-
Study participants meet any of the following criteria will be excluded:
- Requirement for additional temporary or permanent mechanical circulatory support after LVAD implantation;
- Requirement for physician-mandated antiplatelet therapy after implantation due to medical history, surgical history, concomitant surgical procedures, or other conditions, including mandated presence or absence of antiplatelet agent;
- Occurrence of primary endpoint events prior to randomization (within 2-7 days after implantation);
- Inability to take oral medications post-implant through 7 days;
- Known allergy to aspirin;
- Participation in another clinical investigation that may affect study outcome;
- Presence of other comorbid conditions, social or psychological conditions, or other conditions, in the investigator's opinion, that may affect participation in the study or compliance with follow-up requirements.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Placebo group
vitamin K antagonist with placebo
|
Warfarin (INR 2-3) with placebo
|
|
Comparador Ativo: Aspirin group
vitamin K antagonist with aspirin
|
Warfarin (INR 2-3) with aspirin
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Survival free from major hemocompatibility-related adverse events at 12 months post-implantation
Prazo: 12 months post implantation
|
Major hemocompatibility-related adverse events include stroke, suspected or confirmed pump thrombosis, peripheral arterial embolism, myocardial infarction, aortic root thrombosis, and non-surgical major bleeding. Note: Stroke includes ischemic stroke and hemorrhagic stroke. Non-surgical major bleeding is defined as major bleeding events occurring more than 14 days after implantation, including Type 3-5 bleeding events and intracranial hemorrhage that does not meet the definition of hemorrhagic stroke. |
12 months post implantation
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Key Secondary Outcome: Incidence of major thromboembolic events at 12 months post-implantation
Prazo: 12 months post implantation
|
Major thromboembolic events include ischemic stroke, suspected or confirmed pump thrombosis, peripheral arterial embolism, myocardial infarction, and aortic root thrombosis.
|
12 months post implantation
|
|
Incidence of non-surgical bleeding
Prazo: 12 months post implantation
|
including non-surgical major bleeding and hemorrhagic stroke
|
12 months post implantation
|
|
Overall survival rate
Prazo: 12 months post implantation
|
Overall survival rate
|
12 months post implantation
|
|
Incidence of stroke
Prazo: 12 months post implantation
|
Including all stroke, hemorrhagic stroke, ischemic stroke, and disabling stroke
|
12 months post implantation
|
|
Incidence of pump thrombosis
Prazo: 12 months post implantation
|
Including suspected pump thrombosis
|
12 months post implantation
|
|
Incidence of peripheral arterial embolism
Prazo: 12 months post implantation
|
Incidence of peripheral arterial embolism
|
12 months post implantation
|
|
Incidence of myocardial infarction
Prazo: 12 months post implantation
|
Incidence of myocardial infarction
|
12 months post implantation
|
|
Incidence of aortic root thrombosis
Prazo: 12 months post implantation
|
Incidence of aortic root thrombosis
|
12 months post implantation
|
|
Incidence of bleeding
Prazo: 12 months post implantation
|
Including major bleeding, gastrointestinal bleeding, and hemorrhagic stroke
|
12 months post implantation
|
|
Rehospitalization rate
Prazo: 12 months post implantation
|
Rehospitalization rate
|
12 months post implantation
|
|
Hemocompatibility score
Prazo: 12 months post implantation
|
To determine the aggregate net burden of HRAE in each patient, a tiered hierarchal score (hemocompatibility score [HCS]) that weights each event by its escalating clinical relevance was calculated for each patient as previously described.
(Mehra MR.
The burden of haemocompatibility with left ventricular assist systems: a complex weave.
Eur Heart J 2017.
doi: https:// doi.org/10.1093/eurheartj/ehx036.)
In brief, mild events contributed a single point to the HCS, whereas serious events contributed a higher grade to the HCS.
The HCS was calculated for each patient by summing up all the points associated with each HRAE experienced by the patient for the duration of available follow-up.
The HCS served as the net burden of all HRAEs experienced by the patient for the duration of 12-month follow-up.
|
12 months post implantation
|
|
Change in NYHA functional class from baseline
Prazo: 12 months post implantation
|
Change in NYHA functional class from baseline
|
12 months post implantation
|
|
Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline
Prazo: 12 months post implantation
|
Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline
|
12 months post implantation
|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline
Prazo: 12 months post implantation
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline
|
12 months post implantation
|
|
Change in exercise capacity (6-minute walk test) from baseline
Prazo: 12 months post implantation
|
Change in exercise capacity (6-minute walk test) from baseline
|
12 months post implantation
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Embolia e Trombose
- Condições Patológicas, Sinais e Sintomas
- Derrame
- Trombose
- Hemorragia
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Pyrans
- Coumarins
- Benzopyrans
- 4-hidroxicoumarinas
- Varfarina
Outros números de identificação do estudo
- 2026-3116
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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