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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
388
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 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.
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
Proportion of patients with mRS 0-2 at 90 days after randomization
The proportion of patients with modified Rankin Scale (mRS) scores ranging from 0 to 2 at 90 days after randomization.
Time frame: 90 days after randomization
Extended Glasgow Outcome Scale (eGOS) at 90 days
Functional prognosis assessed by Extended Glasgow Outcome Scale (eGOS) at 90 days after randomization.
Time frame: 90 days after randomization
Ordinal shift analysis of mRS at 90 days (mRS 5 and 6 combined)
Ordinal shift analysis of modified Rankin Scale scores at 90 days after randomization, with mRS grade 5 and 6 merged into one category.
Time frame: 90 days after randomization
Proportion of patients with mRS 0-3 at 90 days
Proportion of patients with modified Rankin Scale scores of 0 to 3 at 90 days after randomization.
Time frame: 90 days after randomization
Mini-Mental State Examination (MMSE) score at 90 days
Cognitive function assessed via Mini-Mental State Examination (MMSE) scale.
Time frame: 90 days after randomization
Extended Glasgow Outcome Scale (eGOS) at 1 year
Functional outcome assessed by Extended Glasgow Outcome Scale at 1 year after randomization.
Time frame: 1 year after randomization.
Ordinal shift analysis of mRS at 1 year (mRS 5 and 6 combined)
Ordinal shift analysis of modified Rankin Scale scores at 1 year after randomization, combining mRS 5 and mRS 6 into a single category.
Time frame: 1 year after randomization
Proportion of mRS 0-2 at 1 year
Proportion of patients with modified Rankin Scale scores of 0 to 2 at 1 year after randomization.
Time frame: 1 year after randomization.
Proportion of patients with mRS 0-3 at 1 year
Percentage of subjects achieving modified Rankin Scale scores from 0 to 3 at one year after randomization.
Time frame: 1 year after randomization.
Mini-Mental State Examination (MMSE) score at 1 year
Cognitive function evaluated by Mini-Mental State Examination (MMSE) scale.
Time frame: 1 year after randomization
Change in NIHSS score from baseline at discharge
Changes in National Institutes of Health Stroke Scale (NIHSS) scores at discharge compared with baseline levels.
Time frame: 30 days/discharge, which ever is earlier
Incidence of clinical delayed cerebral ischemia at discharge
Incidence rate of clinical delayed cerebral ischemia (DCI) observed at hospital discharge.
Time frame: 30 days/discharge, which ever is earlier
Percentage of radiological DCI on CT/MRI at discharge
Proportion of patients with radiological delayed cerebral ischemia confirmed by cranial CT or MRI at hospital discharge.
Time frame: 30 days/discharge, which ever is earlier
Lesion volume of radiological DCI on CT/MRI at discharge
Volume of lesions consistent with radiological delayed cerebral ischemia detected by cranial CT or MRI at hospital discharge.
Time frame: 30 days/discharge, which ever is earlier
Incidence of invasive interventions
Incidence of invasive interventions including DSA and angioplasty performed during hospitalization.
Time frame: 30 days/discharge, which ever is earlier
Rate of cerebrospinal fluid shunt surgery within 3 months
Proportion of patients receiving cerebrospinal fluid shunt surgery within 3 months after randomization.
Time frame: Within 3 months after randomization
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