Early Prophylactic Aspirin for Aneurysmal Subarachnoid Hemorrhage
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGanzhou City People's Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Aspirin
DrugAspirin 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
DrugPlacebo 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.
Treatment groups
388 Participants
are divided into 2 treatment groupsGroup A: Aspirin GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 randomizationSecondary outcomes
1
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 randomization2
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 randomization3
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 randomization4
Mini-Mental State Examination (MMSE) score at 90 days
Cognitive function assessed via Mini-Mental State Examination (MMSE) scale.
Time frame
90 days after randomizationOther outcomes
1
All-cause mortality within 90 days after randomization
Total all-cause mortality rate at 90 days after randomization.
Time frame
90 days after randomization2
In-hospital discharge mortality
Mortality rate at the time of hospital discharge.
Time frame
30 days/discharge, which ever is earlier3
Incidence of symptomatic intracerebral hemorrhage
Defined as neurological deterioration with NIHSS score increased by ≥4 points combined with intracranial hemorrhage confirmed by imaging examination.
Time frame
30 days/discharge, which ever is earlier4
Incidence of any new-onset intracranial hemorrhage
Incidence of any new-onset intracranial hemorrhage
Time frame
30 days/discharge, which ever is earlierSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ganzhou City People's Hospital
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
First Affiliated Hospital of Wannan Medical College
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
Affiliated Hospital of Guangdong Medical University
Collaborator
Fifth Affiliated Hospital of Guangzhou Medical University
Collaborator
Meizhou People's Hospital
Collaborator
Guizhou Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Jiangxi Provincial People's Hopital
Collaborator
Huang Shan People's Hospital
Collaborator
Jiujiang No.1 People's Hospital
Collaborator
Ji'an Central People's Hospital
Collaborator
Yichun People's Hospital
Collaborator
Source ClinicalTrials.gov
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