Aspirin 50mg vs 100mg Combined With P2Y12 Inhibitor After PCI (ASPIRE-LD)
The Efficacy and Safety of Aspirin 50mg Versus 100mg in Combination With a P2Y12 Inhibitor After Percutaneous Coronary Intervention: A Randomized, Open-label, Active-controlled, Non-inferiority Trial
This is a randomized, open-label, active-controlled, non-inferiority clinical trial (the ASPIRE-LD trial) conducted in China. It aims to compare the efficacy and safety of low-dose aspirin (50 mg once daily) versus standard-dose aspirin (100 mg once daily), both in combination with a P2Y12 inhibitor, in patients who have successfully undergone percutaneous coronary intervention (PCI) and plan to receive at least 12 months of dual antiplatelet therapy (DAPT).
A total of 2640 eligible patients will be randomly assigned in a 1:1 ratio to receive either 50 mg or 100 mg of enteric-coated aspirin daily, plus a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily, prescribed according to routine clinical practice). All participants will be followed for 12 months after randomization.
The primary goal is to verify that 50 mg aspirin is non-inferior to the 100 mg standard dose in preventing major adverse cardiac and cerebrovascular events (MACCE: cardiovascular death, non-fatal myocardial infarction, definite/probable stent thrombosis, and ischemic stroke) at 12 months post-PCI. If non-inferiority is confirmed, the study will further test whether 50 mg aspirin reduces clinically relevant bleeding events (BARC type 2, 3, or 5) better than the standard dose.
The study is sponsored by the First Hospital of Jilin University and will be carried out in 10-15 tertiary hospitals across China. Its findings will provide evidence for optimizing aspirin dosing in post-PCI DAPT.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background Dual antiplatelet therapy (DAPT) - aspirin combined with a P2Y12 inhibitor - is the standard of care to prevent stent thrombosis and ischemic events after PCI. However, the optimal aspirin dose in combination with modern P2Y12 inhibitors remains undefined, especially in Chinese populations. Current practice widely uses 100 mg daily aspirin, but pharmacological and clinical evidence suggests that lower doses may achieve comparable antiplatelet effect with a lower bleeding risk.
Study Design This is a multicenter, randomized, open-label, active parallel-controlled non-inferiority trial. Enrollment will include 2640 adults with acute or chronic coronary syndrome who have undergone successful PCI and are scheduled for at least 12 months of DAPT. Randomization will be stratified by study center with a 1:1 allocation ratio.
Treatment Regimens
- Experimental group: enteric-coated aspirin 50 mg once daily + a P2Y12 inhibitor
- Control group: enteric-coated aspirin 100 mg once daily + a P2Y12 inhibitor The choice of P2Y12 inhibitor (ticagrelor or clopidogrel) is at the treating physician's discretion based on patient characteristics and clinical guidelines. DAPT will be maintained for a minimum of 12 months.
Outcome Assessment All suspected endpoint events will be independently adjudicated by a blinded Clinical Endpoint Committee according to standardized international definitions. A Data Monitoring Committee will periodically review safety data and study conduct.
Follow-up visits are scheduled at 1 month, 6 months, and 12 months after randomization, including clinical assessment, medication adherence evaluation, and event verification.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Qian Tong, MD
- Número de teléfono: '+86-13074337289'
- Correo electrónico: tongqian187@aliyun.com
Copia de seguridad de contactos de estudio
- Nombre: Mingyou 'Zhang', MD
- Número de teléfono: +86-13689842200
- Correo electrónico: zmy@jlu.edu.cn
Ubicaciones de estudio
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Jilin
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Changchun, Jilin, Porcelana, 130021
- Reclutamiento
- First Hospital of Jilin University
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Contacto:
- Qian Tong, MD
- Número de teléfono: +86-13074337289
- Correo electrónico: tongqian187@aliyun.com
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Contacto:
- Mingyou Zhang, MD
- Número de teléfono: +86-13689842200
- Correo electrónico: zmy@jlu.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged 18 to 85 years at the time of screening
- Diagnosed with acute coronary syndrome (ACS) or chronic coronary syndrome (CCS)
- Has undergone successful percutaneous coronary intervention (PCI) with stent implantation
- Planned to receive at least 12 months of dual antiplatelet therapy (DAPT) with aspirin plus a P2Y12 inhibitor after PCI
- Able to provide written informed consent and comply with study follow-up requirements
Exclusion Criteria:
- Known hypersensitivity or contraindication to aspirin, P2Y12 inhibitors, or related excipients
- High bleeding risk: history of intracranial hemorrhage, gastrointestinal bleeding within 6 months, active bleeding diathesis, or coagulopathy
- Severe hepatic dysfunction (Child-Pugh class C) or severe renal impairment (eGFR < 30 mL/min/1.73 m²)
- Ischemic or hemorrhagic stroke within 3 months before enrollment
- Pregnant or lactating women; women of childbearing potential unwilling to use effective contraception
- Life expectancy < 12 months due to other severe comorbidities such as advanced malignancy
- Participation in another interventional clinical trial within 30 days before screening
- Any other condition judged by the investigator to make the patient unsuitable for the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Low-dose Aspirin
Participants receive enteric-coated aspirin 50 mg once daily, combined with a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily), for at least 12 months after successful percutaneous coronary intervention. |
Enteric-coated aspirin for oral administration, once daily. Two dose levels are studied: 50 mg in the experimental arm and 100 mg in the active comparator arm.
Otros nombres:
Background antiplatelet therapy used in both study arms. Either ticagrelor 90 mg orally twice daily or clopidogrel 75 mg orally once daily, prescribed at the treating physician's discretion according to clinical guidelines.
Otros nombres:
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Comparador activo: Standard-dose Aspirin
Participants receive enteric-coated aspirin 100 mg once daily, combined with a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily), for at least 12 months after successful percutaneous coronary intervention. |
Enteric-coated aspirin for oral administration, once daily. Two dose levels are studied: 50 mg in the experimental arm and 100 mg in the active comparator arm.
Otros nombres:
Background antiplatelet therapy used in both study arms. Either ticagrelor 90 mg orally twice daily or clopidogrel 75 mg orally once daily, prescribed at the treating physician's discretion according to clinical guidelines.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Periodo de tiempo: 12 months after randomization
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Composite endpoint including cardiovascular death, non-fatal myocardial infarction, definite or probable stent thrombosis, and ischemic stroke, independently adjudicated by a blinded clinical endpoint committee. |
12 months after randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Clinically Relevant Bleeding Events
Periodo de tiempo: 12 months after randomization
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Bleeding events classified by the Bleeding Academic Research Consortium (BARC) criteria, including BARC grade 2, 3 and 5. |
12 months after randomization
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Net Adverse Clinical Events (NACE)
Periodo de tiempo: 12 months after randomization
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Composite of all-cause death, myocardial infarction, ischemic stroke and major bleeding. |
12 months after randomization
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007 Dec 13;357(24):2482-94. doi: 10.1056/NEJMra071014. No abstract available.
- Patrono C, Garcia Rodriguez LA, Landolfi R, Baigent C. Low-dose aspirin for the prevention of atherothrombosis. N Engl J Med. 2005 Dec 1;353(22):2373-83. doi: 10.1056/NEJMra052717. No abstract available.
- Patrono C, Ciabattoni G, Patrignani P, Pugliese F, Filabozzi P, Catella F, Davi G, Forni L. Clinical pharmacology of platelet cyclooxygenase inhibition. Circulation. 1985 Dec;72(6):1177-84. doi: 10.1161/01.cir.72.6.1177.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades cardíacas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Isquemia miocardica
- Condiciones Patológicas, Signos y Síntomas
- Enfermedad de la arteria coronaria
- Hemorragia
- El síndrome coronario agudo
- Compuestos de azufre
- Químicos orgánicos
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Ácidos nucleicos, nucleótidos y nucleósidos
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Purinas
- Fenoles
- Derivados de benceno
- Nucleósidos
- Ribonucleósidos
- Tiofenos
- Salicilatos
- Hidroxibenzoates
- Adenosina
- Nucleósidos de purina
- Ticlopidina
- Thienopiridinas
- Ticagrelor
- Clopidogrel
- Aspirina
Otros números de identificación del estudio
- ASPIRE-LD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared to protect patient privacy and confidentiality. This is an investigator-initiated trial without dedicated funding and specialized resources for public data sharing. Aggregate results of the study will be published in peer-reviewed academic journals.
Información sobre medicamentos y dispositivos, documentos del estudio
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