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
Qualifiers
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
Treatments tested in this trial
- Aspirin
- Placebo
Treatment groups
Sponsors and collaborators
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