Monoterapia com PRasugrEl Após Intervenção Coronária Percutânea Primária para Infarto do Miocárdio com Supradesnivelamento do ST (PREMIUM)
The aim of this study is to evaluate the safety of prasugrel monotherapy without aspirin versus 12-month dual antiplatelet therapy (DAPT) in patients with STEMI using platinum-chrome everolimus-eluting stent (PtCr-EES: SYNERGYTM).
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
In the STOPDAPT-2 ACS trial (NCT03462498), ischemic events (especially myocardial infarction) was significantly increased with 1-month DAPT followed by clopidogrel monotherapy, as compared to 12-month DAPT in patients with acute coronary syndrome (ACS). This was potentially attributable to clopidogrel, instead of prasugrel, which is more potent and has less individual difference in efficacy. On the other hand, previous studies including the STOPDAPT-2 ACS that evaluated the safety and efficacy of monotherapy with a P2Y12 inhibitor without aspirin consistently and significantly reduced the risk of bleeding, compared with standard DAPT. Consequently, there has been growing necessity to establish the safety with P2Y12 inhibitor monotherapy in terms of major adverse cardiovascular events. Therefore, we have planned to evaluate the non-inferiority of P2Y12 inhibitor monotherapy with prasugrel versus standard 12-month DAPT with prasugrel and aspirin in terms of the incidence of major cardiovascular events at 12 months after primary PCI in patients with STEMI using Platinum-Chromium Everolimus Eluting Stent (PtCr-EES; SYNERGYTM).
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
Osaka
-
Sayama, Osaka, Japão, 589-8511
- Kindai University Faculty of Medicine
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients scheduled for primary PCI with everolimus-eluting stent (PtCr-EES, SYNERGYTM)
- STEMI patients
- Patients who can continue dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for 12 months
Exclusion Criteria:
- Patients taking anticoagulants
- Patients under 18 years old
- Patients with less than 1 year prognosis
- Patients participating in other intervention studies
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: No aspirin (Prasugrel monotherapy)
To start prasugrel monotherapy before primary percutaneous coronary intervention (PCI). |
12-month prasugrel monotherapy
Outros nomes:
|
|
Comparador Ativo: 12-month DAPT
To start dual antiplatelet therapy with prasugrel and aspirin for 12 months before primary percutaneous coronary intervention (PCI). |
12-month dual antiplatelet therapy with prasugrel and aspirin
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Major adverse cardiovascular events
Prazo: 12 months
|
Composite of all-cause death, myocardial infarction, or stroke |
12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Major secondary bleeding endpoint: Type 3 or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Prazo: 12 months
|
Type 3 or 5 bleeding defined by BARC criteria |
12 months
|
|
All-cause death
Prazo: 12 months
|
Death from any cause |
12 months
|
|
Cardiovascular death
Prazo: 12 months
|
Death from cardiovascular cause |
12 months
|
|
Non-cardiovascular death
Prazo: 12 months
|
Death from non-cardiovascular cause |
12 months
|
|
Myocardial infarction (Periprocedual/ Spontaneous)
Prazo: 12 months
|
Defined by the Academic Research Consortium (ARC)-2 |
12 months
|
|
Stroke (Ischemic/ Haemorrhagic)
Prazo: 12 months
|
Including both ischemic and haemorrhagic stroke |
12 months
|
|
Ischemic stroke
Prazo: 12 months
|
Ischemic stroke with symptom lasting over 24 hours |
12 months
|
|
Hemorrhagic stroke
Prazo: 12 months
|
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma |
12 months
|
|
Stent thrombosis
Prazo: 12 months
|
Stent thrombosis defined by Academic Research Consortium (ARC)-2 definition |
12 months
|
|
Target lesion failure
Prazo: 12 months
|
Cardiovascular death, target vessel myocardial infarction, clinically indicated target lesion revascularization |
12 months
|
|
Target vessel failure
Prazo: 12 months
|
Cardiovascular death, target vessel myocardial infarction, clinically indicated target vessel revascularization |
12 months
|
|
Patient-Oriented Composite Endpoint
Prazo: 12 months
|
All-cause death, stroke, myocardial infarction, and all revascularization, defined by the Academic Research Consortium (ARC)-2 |
12 months
|
|
Any target lesion revascularization
Prazo: 12 months
|
Revascularization to the target lesions (including 5mm of both ends of the stent[s]) regardless of PCI or CABG |
12 months
|
|
Clinically-driven target lesion revascularization
Prazo: 12 months
|
Target lesion revascularization with the anginal symptoms or the positive test for ischemia |
12 months
|
|
Non-target lesion revascularization
Prazo: 12 months
|
Revascularization to non-target lesions regardless PCI or CABG |
12 months
|
|
Coronary artery bypass grafting
Prazo: 12 months
|
Any coronary artery bypass grafting |
12 months
|
|
Any target vessel revascularization
Prazo: 12 months
|
Revascularization to the target vessel |
12 months
|
|
Any coronary revascularization
Prazo: 12 months
|
Revascularization regardless of PCI or CABG |
12 months
|
|
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Prazo: 12 months
|
Type 2 bleeding defined by BARC criteria |
12 months
|
|
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Prazo: 12 months
|
Type 3 bleeding defined by BARC criteria |
12 months
|
|
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Prazo: 12 months
|
Type 4 bleeding defined by BARC criteria |
12 months
|
|
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Prazo: 12 months
|
Type 5 bleeding defined by BARC criteria |
12 months
|
|
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Prazo: 12 months
|
Type 2, 3, or 5 bleeding defined by BARC criteria |
12 months
|
|
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Prazo: 12 months
|
Major bleeding defined by TIMI criteria |
12 months
|
|
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Prazo: 12 months
|
Minor bleeding defined by TIMI criteria |
12 months
|
|
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Prazo: 12 months
|
Major or minor defined by TIMI criteria |
12 months
|
|
Severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Prazo: 12 months
|
Severe bleeding defined by GUSTO criteria |
12 months
|
|
Moderate bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Prazo: 12 months
|
Moderate bleeding defined by GUSTO criteria |
12 months
|
|
Moderate or severe bleeding in Global utilization of streptokinase and tPA for occluded arteries (GUSTO) criteria
Prazo: 12 months
|
Moderate or severe bleeding defined by GUSTO criteria |
12 months
|
|
Intracranial bleeding
Prazo: 12 months
|
Intracranial bleeding regardless of spontaneous or trauma |
12 months
|
|
Gastrointestinal bleeding
Prazo: 12 months
|
Bleeding from gastrointestinal tract regardless of severity |
12 months
|
|
Gastrointestinal complaints
Prazo: 12 months
|
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints |
12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gaku Nakazawa, MD, PhD, Kindai University Faculty of Medicine
Publicações e links úteis
Publicações Gerais
- Inaba S, Ogita M, Suwa S, Kashiwabara K, Wada H, Endo H, Shitara J, Nanasato M, Muramatsu T, Anzai H, Shirakabe A, Yamamoto M, Asaumi Y, Sakuma M, Okayama H, Takahashi K, Otake H, Ikari Y, Kozuma K, Morino Y, Nakazawa G. High Bleeding Risk and Aspirin Omission at the Time of Primary PCI in STEMI: A Post Hoc Analysis of the PREMIUM Trial. J Am Coll Cardiol. 2026 Oct 31:S0735-1097(26)10254-X. doi: 10.1016/j.jacc.2026.10.058. Online ahead of print.
- Takahashi K, Kozuma K, Morino Y, Kashiwabara K, Otake H, Suwa S, Nanasato M, Muramatsu T, Anzai H, Shirakabe A, Yamamoto M, Asaumi Y, Sakuma M, Okayama H, Nakabayashi K, Ogata N, Jujo K, Wakabayashi K, Kusuyama T, Onishi Y, Ashida K, Mitsuhashi Y, Nishimoto Y, Yamazaki S, Kuriyama N, Ikari Y, Nakazawa G; PREMIUM Trial Investigators. Aspirin Omission at the Time of Primary Percutaneous Coronary Intervention in STEMI. N Engl J Med. 2026 Aug 29. doi: 10.1056/NEJMoa2606997. Online ahead of print.
- Takahashi K, Kozuma K, Morino Y, Kashiwabara K, Otake H, Suwa S, Nanasato M, Muramatsu T, Anzai H, Shirakabe A, Yamamoto M, Asaumi Y, Sakuma M, Okayama H, Ikari Y, Nakazawa G. Prasugrel monotherapy versus 12-month dual antiplatelet therapy in STEMI patients undergoing intravascular imaging-guided PCI: Study design and rationale of the randomized PREMIUM trial. Cardiovasc Revasc Med. 2026 Aug;89:30-36. doi: 10.1016/j.carrev.2025.12.007. Epub 2025 Dec 11.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Doenças cardíacas
- Infarte
- Necrose
- Isquemia do miocárdio
- Infarto do miocárdio
- Isquemia
- Condições Patológicas, Sinais e Sintomas
- Infarto do Miocárdio com Elevação do ST
- Síndrome Coronariana Aguda
- 2'-desoxitimidilil- (3'-5 ')-2'-desoxiadenosina
- N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester
Outros números de identificação do estudo
- Y0140
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .