- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07642427
Early Prophylactic Aspirin for Aneurysmal Subarachnoid Hemorrhage (aSAH-ASA)
7 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
388
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Weilong Huang, MD. PhD.
- Numero di telefono: +8618807971121
- Email: doctorhwl@163.com
Backup dei contatti dello studio
- Nome: Zhenyu zhang, MD. PhD.
- Numero di telefono: +8615297777969
- Email: 623071778@qq.com
Luoghi di studio
-
-
Jiangxi
-
Ganzhou, Jiangxi, Cina, 341000
- Ganzhou People's Hospital
-
Contatto:
- Qiuhuang Jiang, MD, PhD
- Numero di telefono: +8613607979100
- Email: jiangqh1968@126.com
-
Contatto:
- Xinyun Ye, MD, PhD
- Numero di telefono: +8615979789987
- Email: yexinyun1270@163.com
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore placebo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of patients with mRS 0-2 at 90 days after randomization
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Extended Glasgow Outcome Scale (eGOS) at 90 days
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Incidence of clinical delayed cerebral ischemia at discharge
Lasso di tempo: 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
|
|
Percentage of radiological DCI on CT/MRI at discharge
Lasso di tempo: 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
|
|
Lesion volume of radiological DCI on CT/MRI at discharge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Within 3 months after randomization
|
Proportion of patients receiving cerebrospinal fluid shunt surgery within 3 months after randomization.
|
Within 3 months after randomization
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
All-cause mortality within 90 days after randomization
Lasso di tempo: 90 days after randomization
|
Total all-cause mortality rate at 90 days after randomization.
|
90 days after randomization
|
|
In-hospital discharge mortality
Lasso di tempo: 30 days/discharge, which ever is earlier
|
Mortality rate at the time of hospital discharge.
|
30 days/discharge, which ever is earlier
|
|
Incidence of symptomatic intracerebral hemorrhage
Lasso di tempo: 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.
|
30 days/discharge, which ever is earlier
|
|
Incidence of any new-onset intracranial hemorrhage
Lasso di tempo: 30 days/discharge, which ever is earlier
|
Incidence of any new-onset intracranial hemorrhage
|
30 days/discharge, which ever is earlier
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: QiuHua Jiang, MD. PhD., Ganzhou People's Hospital, Ganzhou, Jiangxi Province, China
- Investigatore principale: Zeguang Ren, MD. PhD., Houston Methodist, Houston, USA
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 giugno 2026
Completamento primario (Stimato)
1 maggio 2029
Completamento dello studio (Stimato)
1 agosto 2029
Date di iscrizione allo studio
Primo inviato
28 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
7 giugno 2026
Primo Inserito (Effettivo)
11 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Processi patologici
- Emorragia
- Emorragie intracraniche
- Condizioni patologiche, segni e sintomi
- Emorragia subaracnoidea
- Prodotti chimici organici
- Idrocarburi
- Idrocarburi, ciclici
- Idrocarburi, aromatici
- Fenoli
- Derivati di benzene
- Salicilati
- Idrossibenzoati
- Aspirina
Altri numeri di identificazione dello studio
- GZPH-PJB2025-420-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Individual participant data (IPD) cannot be shared due to patient privacy requirements, institutional policies, and legal and regulatory restrictions.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Aspirin
-
Galala UniversityCompletatoFegato grasso non alcolico | Diabete di tipo 2Egitto