Early Prophylactic Aspirin for Aneurysmal Subarachnoid Hemorrhage

Summary

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.

Conditions

• Aneurysmal Subarachnoid Hemorrhage (aSAH)
• Delayed Cerebral Ischemia

Interventions

DRUG

Aspirin

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.

DRUG

Placebo

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• First Affiliated Hospital of Wannan Medical College

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Affiliated Hospital of Guangdong Medical University

  collaborator OTHER

• Fifth Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Meizhou People's Hospital

  collaborator OTHER

• Guizhou Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Jiangxi Provincial People's Hopital

  collaborator OTHER

• Huang Shan People's Hospital

  collaborator OTHER

• Jiujiang No.1 People's Hospital

  collaborator OTHER

• Ji'an Central People's Hospital

  collaborator UNKNOWN

• Yichun People's Hospital

  collaborator UNKNOWN

• Ganzhou City People's Hospital

  lead OTHER

Principal Investigators

• QiuHua Jiang, MD. PhD. · Ganzhou People's Hospital, Ganzhou, Jiangxi Province, China

• Zeguang Ren, MD. PhD. · Houston Methodist, Houston, USA

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2029-05-31

Completion

2029-08-31

Countries

• China

Study Locations