- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07642427
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
Status
Noch keine Rekrutierung
Intervention / Behandlung
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:
- Qiuhuang Jiang, MD, PhD
- Telefonnummer: +8613607979100
- E-Mail: jiangqh1968@126.com
-
Kontakt:
- Xinyun Ye, MD, PhD
- Telefonnummer: +8615979789987
- E-Mail: yexinyun1270@163.com
-
-
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:
- 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.
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.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: QiuHua Jiang, MD. PhD., Ganzhou People's Hospital, Ganzhou, Jiangxi Province, China
- Hauptermittler: Zeguang Ren, MD. PhD., Houston Methodist, Houston, USA
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
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Zerebrovaskuläre Erkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Pathologische Prozesse
- Blutung
- Intrakranielle Blutungen
- Pathologische Zustände, Anzeichen und Symptome
- Subarachnoidalblutung
- Organische Chemikalien
- Kohlenwasserstoffe
- Kohlenwasserstoffe, zyklisch
- Kohlenwasserstoffe, aromatisch
- Phenole
- Benzolderivate
- Salicylate
- Hydroxybenzoates
- Aspirin
Andere Studien-ID-Nummern
- GZPH-PJB2025-420-01
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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