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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07642427
Early Prophylactic Aspirin for Aneurysmal Subarachnoid Hemorrhage (aSAH-ASA)
7 de junio de 2026 actualizado por: Ganzhou City People's Hospital
Study on the Efficacy and Safety of Early Prophylactic Use of Aspirin in Improving Prognosis of Patients With Aneurysmal Subarachnoid Hemorrhage: A Multicenter, Prospective, Double-Blind, Randomized Controlled Trial
This study is a multicenter, prospective, double-blind, randomized controlled trial designed to evaluate whether early prophylactic use of aspirin improves functional outcomes in patients with aneurysmal subarachnoid hemorrhage (aSAH).
Patients with aSAH who have undergone successful aneurysm securing will be randomly assigned to receive either aspirin plus standard care or a placebo plus standard care.
The study drug will be started within 48 hours of undergone successful aneurysm securing and continued for not less than 10 days and not more than 14 consecutive days.
The main goal is to compare the rate of favorable functional outcomes at 3 months between the two groups.
Secondary goals include evaluating the incidence of delayed cerebral ischemia, cerebral infarction, mortality, and safety outcomes such as major bleeding events.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening neurological emergency associated with high rates of morbidity and mortality.
Delayed cerebral ischemia (DCI) and subsequent cerebral infarction are major contributors to poor functional outcomes in survivors.
Antiplatelet agents such as aspirin have been hypothesized to reduce the risk of microthrombosis and DCI, but evidence for their early prophylactic use in aSAH remains limited and controversial.
This trial aims to investigate the efficacy and safety of early aspirin administration in improving long-term functional outcomes in aSAH patients.
Eligible patients will be randomized into two groups: the intervention group will receive 100 mg of oral aspirin daily for not less than 10 days and not more than 14 consecutive days, while the control group will receive an identical placebo.
All patients in both groups will receive standardized aSAH management according to current clinical guidelines, including nimodipine, blood pressure control, and supportive care.
The primary endpoint is the functional outcome measured by the modified Rankin Scale (mRS) at 3 months.
Secondary endpoints include incidence of clinical DCI at discharge, percentage of imaging DCI detected on CT/MRI at discharge, all-cause mortality at 3 months, and safety outcomes including major bleeding events.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
388
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Weilong Huang, MD. PhD.
- Número de teléfono: +8618807971121
- Correo electrónico: doctorhwl@163.com
Copia de seguridad de contactos de estudio
- Nombre: Zhenyu zhang, MD. PhD.
- Número de teléfono: +8615297777969
- Correo electrónico: 623071778@qq.com
Ubicaciones de estudio
-
-
Jiangxi
-
Ganzhou, Jiangxi, Porcelana, 341000
- Ganzhou People's Hospital
-
Contacto:
- Qiuhuang Jiang, MD, PhD
- Número de teléfono: +8613607979100
- Correo electrónico: jiangqh1968@126.com
-
Contacto:
- Xinyun Ye, MD, PhD
- Número de teléfono: +8615979789987
- Correo electrónico: yexinyun1270@163.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥ 18 years and ≤ 80 years.
- Spontaneous subarachnoid hemorrhage (SAH) confirmed by non-contrast head CT.
- Diagnosis of ruptured intracranial aneurysm confirmed, and successfully treated by either surgical clipping or endovascular coiling within 48 hours of ictus.
- Hunt-Hess grade ≤ 4 or WFNS grade ≤ 4 (assessed within 48 hours of SAH onset).
- Fisher grade 2-4 or modified Fisher grade 1-4.
- No significant focal neurological deficit after aneurysm intervention, defined as NIHSS scores ≤ 1 in the following items: 5a (left arm motor), 5b (right arm motor), 6a (left leg motor), 6b (right leg motor), and 9 (language).
- Pre-morbid modified Rankin Scale (mRS) score ≤ 1 prior to SAH onset.
Exclusion Criteria:
- Hunt-Hess grade 5 or WFNS grade 5 (assessed within 48 hours of SAH onset).
- Patients requiring any intracranial stent or non-embolic intrasaccular device during aneurysm embolization, with post-procedural need for antiplatelet therapy.
- Angiogram-negative SAH.
- Note: Prior history of ruptured intracranial aneurysm or re-rupture of previously treated aneurysm is not excluded.
- Moderate-to-severe vasospasm demonstrated on pre-operative or intra-operative CTA/DSA in the emergency setting.
- SAH caused by non-saccular aneurysms, including mycotic, blood-blister, fusiform, or dissecting aneurysms, or cases without basal cistern subarachnoid hemorrhage.
- Significant pre-existing intracranial pathology at the time of enrollment, including but not limited to: traumatic brain injury, moyamoya disease, high suspicion or documented CNS vasculitis, severe fibromuscular dysplasia, arteriovenous malformation, arteriovenous fistula, significant cervical or intracranial atherosclerotic stenosis (≥70%), or malignant brain tumor.
- Medical conditions requiring chronic use of antiplatelet agents (aspirin, clopidogrel, or ticagrelor), such as transient ischemic attack, myocardial infarction, atrial fibrillation, prosthetic heart valve, arteriovenous fistula, unstable angina, or other conditions requiring thromboprophylaxis.
- Thrombocytopenia (platelet count <20,000/μL, excluding aggregation artifacts), active disseminated intravascular coagulation (DIC) at enrollment, or documented history of coagulopathy or bleeding diathesis.
- History of gastrointestinal bleeding or major systemic hemorrhage within 30 days, hemoglobin <8 g/dL at admission, INR ≥1.5, or severe hepatic impairment defined as AST, ALT, alkaline phosphatase (AP), or GGT >2 times the upper limit of normal.
- Creatinine clearance <30 mL/min.
- Severe comorbidities that may confound study outcomes, including but not limited to: multiple sclerosis, dementia, major depression, immunosuppressed state or during intensive immunosuppressive therapy, cancer with expected survival <1 year, multi-organ failure, or any other condition potentially causing cognitive impairment.
Contraindications to aspirin therapy, including:
- Hypersensitivity to aspirin, other salicylates, or any excipients in the formulation;
- History of asthma induced by salicylates or NSAIDs;
- Active peptic ulcer disease;
- Bleeding diathesis;
- Hepatic or renal failure;
- Uncontrolled severe heart failure;
- Concomitant use with methotrexate at doses ≥15 mg/week.
- Pregnancy or positive HCG test.
- Incomplete repair of the responsible aneurysm as judged by the treating physician, with high risk of early re-bleeding.
- History of head trauma within 3 months prior to SAH onset.
- Recent cerebral disease within 3 months prior to SAH onset, such as tumor, stroke, epilepsy, vasculitis, AVM, or hydrocephalus.
- History of psychiatric illness or seizure disorder.
- Breastfeeding women.
- Expected survival <1 year prior to SAH onset.
- Participation in another randomized clinical trial that may confound the evaluation of this study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Aspirin Group
Patients receive 100 mg aspirin once daily, initiated within 48 hours of undergone successful aneurysm securing and continued for not less than 10 consecutive days and not more than 14 consecutive days, plus standard care.
|
Aspirin 100 mg (1 tablet) administered orally, via nasogastric tube, or rectally within 48 hours after aneurysm embolization or surgical clipping, once daily, for a minimum of 10 consecutive days and a maximum of 14 consecutive days.
|
|
Comparador de placebos: Placebo Control Group
Patients receive identical-appearing placebo capsules once daily, initiated within 48 hours of undergone successful aneurysm securing and continued for not less than 10 consecutive days and not more than 14 consecutive days, plus standard care.
|
Placebo 1 tablet (identical in appearance to aspirin 100 mg) administered orally, via nasogastric tube, or rectally within 48 hours after aneurysm embolization or surgical clipping, once daily, for a minimum of 10 consecutive days and a maximum of 14 consecutive days.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of patients with mRS 0-2 at 90 days after randomization
Periodo de tiempo: 90 days after randomization
|
The proportion of patients with modified Rankin Scale (mRS) scores ranging from 0 to 2 at 90 days after randomization.
|
90 days after randomization
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Extended Glasgow Outcome Scale (eGOS) at 90 days
Periodo de tiempo: 90 days after randomization
|
Functional prognosis assessed by Extended Glasgow Outcome Scale (eGOS) at 90 days after randomization.
|
90 days after randomization
|
|
Ordinal shift analysis of mRS at 90 days (mRS 5 and 6 combined)
Periodo de tiempo: 90 days after randomization
|
Ordinal shift analysis of modified Rankin Scale scores at 90 days after randomization, with mRS grade 5 and 6 merged into one category.
|
90 days after randomization
|
|
Proportion of patients with mRS 0-3 at 90 days
Periodo de tiempo: 90 days after randomization
|
Proportion of patients with modified Rankin Scale scores of 0 to 3 at 90 days after randomization.
|
90 days after randomization
|
|
Mini-Mental State Examination (MMSE) score at 90 days
Periodo de tiempo: 90 days after randomization
|
Cognitive function assessed via Mini-Mental State Examination (MMSE) scale.
|
90 days after randomization
|
|
Extended Glasgow Outcome Scale (eGOS) at 1 year
Periodo de tiempo: 1 year after randomization.
|
Functional outcome assessed by Extended Glasgow Outcome Scale at 1 year after randomization.
|
1 year after randomization.
|
|
Ordinal shift analysis of mRS at 1 year (mRS 5 and 6 combined)
Periodo de tiempo: 1 year after randomization
|
Ordinal shift analysis of modified Rankin Scale scores at 1 year after randomization, combining mRS 5 and mRS 6 into a single category.
|
1 year after randomization
|
|
Proportion of mRS 0-2 at 1 year
Periodo de tiempo: 1 year after randomization.
|
Proportion of patients with modified Rankin Scale scores of 0 to 2 at 1 year after randomization.
|
1 year after randomization.
|
|
Proportion of patients with mRS 0-3 at 1 year
Periodo de tiempo: 1 year after randomization.
|
Percentage of subjects achieving modified Rankin Scale scores from 0 to 3 at one year after randomization.
|
1 year after randomization.
|
|
Mini-Mental State Examination (MMSE) score at 1 year
Periodo de tiempo: 1 year after randomization
|
Cognitive function evaluated by Mini-Mental State Examination (MMSE) scale.
|
1 year after randomization
|
|
Change in NIHSS score from baseline at discharge
Periodo de tiempo: 30 days/discharge, which ever is earlier
|
Changes in National Institutes of Health Stroke Scale (NIHSS) scores at discharge compared with baseline levels.
|
30 days/discharge, which ever is earlier
|
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Incidence of clinical delayed cerebral ischemia at discharge
Periodo de tiempo: 30 days/discharge, which ever is earlier
|
Incidence rate of clinical delayed cerebral ischemia (DCI) observed at hospital discharge.
|
30 days/discharge, which ever is earlier
|
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Percentage of radiological DCI on CT/MRI at discharge
Periodo de tiempo: 30 days/discharge, which ever is earlier
|
Proportion of patients with radiological delayed cerebral ischemia confirmed by cranial CT or MRI at hospital discharge.
|
30 days/discharge, which ever is earlier
|
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Lesion volume of radiological DCI on CT/MRI at discharge
Periodo de tiempo: 30 days/discharge, which ever is earlier
|
Volume of lesions consistent with radiological delayed cerebral ischemia detected by cranial CT or MRI at hospital discharge.
|
30 days/discharge, which ever is earlier
|
|
Incidence of invasive interventions
Periodo de tiempo: 30 days/discharge, which ever is earlier
|
Incidence of invasive interventions including DSA and angioplasty performed during hospitalization.
|
30 days/discharge, which ever is earlier
|
|
Rate of cerebrospinal fluid shunt surgery within 3 months
Periodo de tiempo: Within 3 months after randomization
|
Proportion of patients receiving cerebrospinal fluid shunt surgery within 3 months after randomization.
|
Within 3 months after randomization
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
All-cause mortality within 90 days after randomization
Periodo de tiempo: 90 days after randomization
|
Total all-cause mortality rate at 90 days after randomization.
|
90 days after randomization
|
|
In-hospital discharge mortality
Periodo de tiempo: 30 days/discharge, which ever is earlier
|
Mortality rate at the time of hospital discharge.
|
30 days/discharge, which ever is earlier
|
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Incidence of symptomatic intracerebral hemorrhage
Periodo de tiempo: 30 days/discharge, which ever is earlier
|
Defined as neurological deterioration with NIHSS score increased by ≥4 points combined with intracranial hemorrhage confirmed by imaging examination.
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30 days/discharge, which ever is earlier
|
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Incidence of any new-onset intracranial hemorrhage
Periodo de tiempo: 30 days/discharge, which ever is earlier
|
Incidence of any new-onset intracranial hemorrhage
|
30 days/discharge, which ever is earlier
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: QiuHua Jiang, MD. PhD., Ganzhou People's Hospital, Ganzhou, Jiangxi Province, China
- Investigador principal: Zeguang Ren, MD. PhD., Houston Methodist, Houston, USA
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de mayo de 2029
Finalización del estudio (Estimado)
1 de agosto de 2029
Fechas de registro del estudio
Enviado por primera vez
28 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Hemorragia
- Hemorragias intracraneales
- Condiciones Patológicas, Signos y Síntomas
- Hemorragia subaracnoidea
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Fenoles
- Derivados de benceno
- Salicilatos
- Hidroxibenzoates
- Aspirina
Otros números de identificación del estudio
- GZPH-PJB2025-420-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data (IPD) cannot be shared due to patient privacy requirements, institutional policies, and legal and regulatory restrictions.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .