Early Prophylactic Aspirin for Aneurysmal Subarachnoid Hemorrhage

NCT07642427 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: GZPH-PJB2025-420-01
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Aneurysmal subarachnoid hemorrhage; Aspirin; Delayed cerebral ischemia; Antiplatelet therapy; Functional outcome; Randomized controlled trial

Outcome Measures

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.

  90 days after randomization

Secondary Outcomes (15)

• Extended Glasgow Outcome Scale (eGOS) at 90 days

  90 days after randomization

• Ordinal shift analysis of mRS at 90 days (mRS 5 and 6 combined)

  90 days after randomization

• Proportion of patients with mRS 0-3 at 90 days

  90 days after randomization

• Mini-Mental State Examination (MMSE) score at 90 days

  90 days after randomization

• Extended Glasgow Outcome Scale (eGOS) at 1 year

  1 year after randomization.

Other Outcomes (4)

• All-cause mortality within 90 days after randomization

  90 days after randomization

• In-hospital discharge mortality

  30 days/discharge, which ever is earlier

• Incidence of symptomatic intracerebral hemorrhage

  30 days/discharge, which ever is earlier

Study Arms (2)

Aspirin Group

EXPERIMENTAL

Patients receive 100 mg aspirin once daily, initiated within 48 hours of undergone successful aneurysm securing and continued for not less than 10 consecutive days and not more than 14 consecutive days, plus standard care.

Drug: Aspirin

Placebo Control Group

PLACEBO COMPARATOR

Patients receive identical-appearing placebo capsules once daily, initiated within 48 hours of undergone successful aneurysm securing and continued for not less than 10 consecutive days and not more than 14 consecutive days, plus standard care.

Drug: Placebo

Interventions

Aspirin DRUG

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.

Aspirin Group

Placebo DRUG

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.

Placebo Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Fisher grade 2-4 or modified Fisher grade 1-4.
• No significant focal neurological deficit after aneurysm intervention, defined as NIHSS scores ≤ 1 in the following items: 5a (left arm motor), 5b (right arm motor), 6a (left leg motor), 6b (right leg motor), and 9 (language).
• Pre-morbid modified Rankin Scale (mRS) score ≤ 1 prior to SAH onset.

You may not qualify if:

• 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.
• Moderate-to-severe vasospasm demonstrated on pre-operative or intra-operative CTA/DSA in the emergency setting.
• SAH caused by non-saccular aneurysms, including mycotic, blood-blister, fusiform, or dissecting aneurysms, or cases without basal cistern subarachnoid hemorrhage.
• Significant pre-existing intracranial pathology at the time of enrollment, including but not limited to: traumatic brain injury, moyamoya disease, high suspicion or documented CNS vasculitis, severe fibromuscular dysplasia, arteriovenous malformation, arteriovenous fistula, significant cervical or intracranial atherosclerotic stenosis (≥70%), or malignant brain tumor.
• Medical conditions requiring chronic use of antiplatelet agents (aspirin, clopidogrel, or ticagrelor), such as transient ischemic attack, myocardial infarction, atrial fibrillation, prosthetic heart valve, arteriovenous fistula, unstable angina, or other conditions requiring thromboprophylaxis.
• Thrombocytopenia (platelet count \<20,000/μL, excluding aggregation artifacts), active disseminated intravascular coagulation (DIC) at enrollment, or documented history of coagulopathy or bleeding diathesis.
• History of gastrointestinal bleeding or major systemic hemorrhage within 30 days, hemoglobin \<8 g/dL at admission, INR ≥1.5, or severe hepatic impairment defined as AST, ALT, alkaline phosphatase (AP), or GGT \>2 times the upper limit of normal.
• Creatinine clearance \<30 mL/min.
• Severe comorbidities that may confound study outcomes, including but not limited to: multiple sclerosis, dementia, major depression, immunosuppressed state or during intensive immunosuppressive therapy, cancer with expected survival \<1 year, multi-organ failure, or any other condition potentially causing cognitive impairment.
• Contraindications to aspirin therapy, including:
• Hypersensitivity to aspirin, other salicylates, or any excipients in the formulation;
• History of asthma induced by salicylates or NSAIDs;

Sponsors & Collaborators

• Ganzhou City People's Hospital: lead
• 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
• Jiu Jiang NO.1 People's Hospital: collaborator
• Ji'an Central People's Hospital: collaborator
• Yichun People's Hospital: collaborator

Study Sites (1)

Ganzhou People's Hospital

Ganzhou, Jiangxi, 341000, China

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• QiuHua Jiang, MD. PhD.

  Ganzhou People's Hospital, Ganzhou, Jiangxi Province, China

  PRINCIPAL INVESTIGATOR

• Zeguang Ren, MD. PhD.

  Houston Methodist, Houston, USA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weilong Huang, MD. PhD.

CONTACT

+8618807971121; doctorhwl@163.com

Zhenyu zhang, MD. PhD.

CONTACT

+8615297777969; 623071778@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study drug (aspirin/placebo) is prepared in identical capsules to maintain blinding. All study personnel and participants remain blinded to treatment assignment throughout the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, parallel-group study. Eligible patients with aSAH will be assigned to either the aspirin intervention group or the placebo control group in a 1:1 ratio.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)