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

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

388 Participants
are divided into 2 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