Cilostazol to help prevent delayed brain ischemia after aneurysm bleed

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter Phase 3 randomized trial will enroll adults 18-80 with aneurysmal subarachnoid hemorrhage who recently had aneurysm repair. Participants will be randomized to receive cilostazol 100 mg twice daily or placebo for a defined period, with the goal of lowering delayed cerebral ischemia and improving neurological prognosis while monitoring safety. Enrollment targets 316 patients across 30 hospitals in China. Eligible participants must have Hunt-Hess grades II-IV, no rebleeding within 6 hours post-surgery, and no contraindications to cilostazol. Exclusion criteria include multiple aneurysms, preexisting significant disability, and comorbid conditions that increase risk or confound outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18-80 years.
* Diagnosed with subarachnoid hemorrhage (SAH) by computed tomography (CT) scan, and the responsible aneurysm is clearly identified by computed tomography angiography (CTA) or digital subtraction angiography (DSA).
* Received aneurysm coil embolization or craniotomy clipping within 72 hours of symptom onset.
* Hunt-Hess grade II-IV.
* No rebleeding or new intracranial hemorrhage is shown on head CT within 6 hours after surgery.
* Understand and follow the procedures of clinical trial, participate voluntarily and sign the informed consent (the informed consent can be signed voluntarily by the person or guardian)

Exclusion Criteria:

* Multiple aneurysms (\>1aneurysms confirmed by CTA/DSA)
* Modified Rankin Scale (mRS) score ≥ 3 before onset
* Patients with contraindications to cilostazol use:

  1. Allergy to cilostazol
  2. Severe heart failure（New York Heart Association (NYHA) Functional Classification Grade III or IV）
  3. Coagulation disorders or systemic bleeding (e.g., hemophilia, gastrointestinal bleeding, hemoptysis, etc.)
  4. Pregnant or lactating women
* Patients with severe organic diseases and an expected survival time of less than 90 days
* Severe liver insufficiency or renal insufficiency before randomization
* Aneurysm treatment requiring the use of other antiplatelet drugs after interventional therapy
* Currently receiving treatment with other investigational drugs or device trials

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Liping Liu
• Email: lipingsister@gmail.com
• Phone: +86-010-59978328

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nitric Oxide Use to Predict Vasospasm in Aneurysmal Subarachnoid Hemorrhage

  This study tests whether nitric oxide consumption in CSF can predict cerebral vasospasm in patients with aneurysmal SAH.

  Recruiting at 2 sites Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT07614906

• Multi-omics program to understand complications and outcomes after aneurysmal subarachnoid hemorrhage

  This project will test if combining blood, cerebrospinal fluid, urine, imaging, and multi-omics data can find biomarkers that predict complications and outcomes in adults with aneurysmal subarachnoid hemorrhage.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07270419

• Dome-only coiling for severe aneurysmal subarachnoid hemorrhage

  This will test a minimally invasive dome-protection coiling procedure to prevent re-bleeding in adults who have had a severe aneurysmal subarachnoid hemorrhage.

  Recruiting University of Louisville · Louisville, Kentucky · NCT07250958

• Transcutaneous Vagal Nerve Stimulation to help with brain vessel narrowing after aneurysm rupture

  This trial tests whether using a noninvasive nerve stimulation device can reduce cerebral vasospasm after an aneurysmal brain bleed in adults 18–65 who are undergoing standard treatment.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07131696

• Tocilizumab-aazg to reduce stroke risk after a ruptured brain aneurysm

  This trial will try to see if a single IV dose of tocilizumab-aazg is safe and can help prevent delayed strokes in adults who have had a ruptured brain aneurysm (aneurysmal subarachnoid hemorrhage).

  Recruiting Phase 1 University of Florida · Gainesville, Florida · NCT06863480

• Using human albumin to improve outcomes in patients with aneurysmal subarachnoid hemorrhage

  This study is testing if giving human albumin to patients with a type of brain hemorrhage can help improve their recovery compared to standard fluid treatments.

  Recruiting Hamad Medical Corporation · Doha · NCT06548477

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.