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Early Prophylactic Aspirin for Aneurysmal Subarachnoid Hemorrhage (aSAH-ASA)

7. června 2026 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

388

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Weilong Huang, MD. PhD.
  • Telefonní číslo: +8618807971121
  • E-mail: doctorhwl@163.com

Studijní záloha kontaktů

  • Jméno: Zhenyu zhang, MD. PhD.
  • Telefonní číslo: +8615297777969
  • E-mail: 623071778@qq.com

Studijní místa

    • Jiangxi
      • Ganzhou, Jiangxi, Čína, 341000
        • Ganzhou People's Hospital
        • Kontakt:
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 80 years.
  2. Spontaneous subarachnoid hemorrhage (SAH) confirmed by non-contrast head CT.
  3. Diagnosis of ruptured intracranial aneurysm confirmed, and successfully treated by either surgical clipping or endovascular coiling within 48 hours of ictus.
  4. Hunt-Hess grade ≤ 4 or WFNS grade ≤ 4 (assessed within 48 hours of SAH onset).
  5. Fisher grade 2-4 or modified Fisher grade 1-4.
  6. 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).
  7. Pre-morbid modified Rankin Scale (mRS) score ≤ 1 prior to SAH onset.

Exclusion Criteria:

  1. Hunt-Hess grade 5 or WFNS grade 5 (assessed within 48 hours of SAH onset).
  2. Patients requiring any intracranial stent or non-embolic intrasaccular device during aneurysm embolization, with post-procedural need for antiplatelet therapy.
  3. Angiogram-negative SAH.
  4. Note: Prior history of ruptured intracranial aneurysm or re-rupture of previously treated aneurysm is not excluded.
  5. Moderate-to-severe vasospasm demonstrated on pre-operative or intra-operative CTA/DSA in the emergency setting.
  6. SAH caused by non-saccular aneurysms, including mycotic, blood-blister, fusiform, or dissecting aneurysms, or cases without basal cistern subarachnoid hemorrhage.
  7. 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.
  8. 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.
  9. Thrombocytopenia (platelet count <20,000/μL, excluding aggregation artifacts), active disseminated intravascular coagulation (DIC) at enrollment, or documented history of coagulopathy or bleeding diathesis.
  10. 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.
  11. Creatinine clearance <30 mL/min.
  12. 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.
  13. 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.
  14. Pregnancy or positive HCG test.
  15. Incomplete repair of the responsible aneurysm as judged by the treating physician, with high risk of early re-bleeding.
  16. History of head trauma within 3 months prior to SAH onset.
  17. Recent cerebral disease within 3 months prior to SAH onset, such as tumor, stroke, epilepsy, vasculitis, AVM, or hydrocephalus.
  18. History of psychiatric illness or seizure disorder.
  19. Breastfeeding women.
  20. Expected survival <1 year prior to SAH onset.
  21. Participation in another randomized clinical trial that may confound the evaluation of this study.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Komparátor placeba: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of patients with mRS 0-2 at 90 days after randomization
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Extended Glasgow Outcome Scale (eGOS) at 90 days
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Within 3 months after randomization
Proportion of patients receiving cerebrospinal fluid shunt surgery within 3 months after randomization.
Within 3 months after randomization

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
All-cause mortality within 90 days after randomization
Časové okno: 90 days after randomization
Total all-cause mortality rate at 90 days after randomization.
90 days after randomization
In-hospital discharge mortality
Časové okno: 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
Časové okno: 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
Časové okno: 30 days/discharge, which ever is earlier
Incidence of any new-onset intracranial hemorrhage
30 days/discharge, which ever is earlier

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. května 2029

Dokončení studie (Odhadovaný)

1. srpna 2029

Termíny zápisu do studia

První předloženo

28. května 2026

První předloženo, které splnilo kritéria kontroly kvality

7. června 2026

První zveřejněno (Aktuální)

11. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data (IPD) cannot be shared due to patient privacy requirements, institutional policies, and legal and regulatory restrictions.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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