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

7. Juni 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

388

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Weilong Huang, MD. PhD.
  • Telefonnummer: +8618807971121
  • E-Mail: doctorhwl@163.com

Studieren Sie die Kontaktsicherung

  • Name: Zhenyu zhang, MD. PhD.
  • Telefonnummer: +8615297777969
  • E-Mail: 623071778@qq.com

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Placebo-Komparator: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients with mRS 0-2 at 90 days after randomization
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Extended Glasgow Outcome Scale (eGOS) at 90 days
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Within 3 months after randomization
Proportion of patients receiving cerebrospinal fluid shunt surgery within 3 months after randomization.
Within 3 months after randomization

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
All-cause mortality within 90 days after randomization
Zeitfenster: 90 days after randomization
Total all-cause mortality rate at 90 days after randomization.
90 days after randomization
In-hospital discharge mortality
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 30 days/discharge, which ever is earlier
Incidence of any new-onset intracranial hemorrhage
30 days/discharge, which ever is earlier

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Mai 2029

Studienabschluss (Geschätzt)

1. August 2029

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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