Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage (CAPTAIN)

November 18, 2025 updated by: Beijing Tiantan Hospital

Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage: A Prospective, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial

The investigators propose to conduct a multicenter randomized trial to test whether cilostazol reduces the incidence of delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) and improves patients' neurological prognosis, while assessing its safety.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators propose to conduct a multicenter randomized trial to test the primary hypothesis of whether cilostazol reduces the incidence of delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) and improves patients' neurological prognosis, while assessing its safety. The investigators will recruit 316 patients from 30 hospitals in China. Eligibility criteria for the trial participants include Aged 18-80 years. Diagnosed with subarachnoid hemorrhage (SAH) by computed tomography (CT) scan, and the responsible aneurysm is 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). Patients with multiple aneurysms, Modified Rankin Scale (mRS) score ≥ 3 before onset, contraindications to cilostazol use, 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, receiving treatment with other investigational drugs or device trials currently will be excluded. Patients will be randomly assigned to the experimental group or control group at a 1:1 ratio. Experimental Group patients will receive cilostazol 100 mg twice daily for 14 consecutive days, in addition to the standard aSAH treatment. Control Group patients will receive a placebo twice daily (bid) for 14 consecutive days, in addition to the standard aSAH treatment. The primary study endpoint is incidence of delayed cerebral ischemia (DCI) in patients with aneurysmal subarachnoid hemorrhage (aSAH) within 14±2 days after randomization. Other secondary endpoints include neurological function prognosis at 90±7 days after randomization, incidence of intracranial rebleeding events within 90±7 days after randomization, incidence of other severe bleeding events within 90±7 days after randomization. This trial will provide important information for the development of clinical guidelines for reducing delayed cerebral ischemia (DCI) in patients with aneurysmal subarachnoid hemorrhage (aSAH).

Study Type

Interventional

Enrollment (Estimated)

316

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cilostazol Group
Administer 100 mg cilostazol, twice daily for 14 days and the standard aneurysmal subarachnoid treatment pathway.
Drug: Cilostazol 100 mg BID
Within 24 hours after randomization, patients will receive cilostazol 100 mg twice daily (BID) for 14 consecutive days, in addition to the standard aSAH treatment.
Placebo Comparator: Control Group
Implement placebo 100mg twice daily for 14 days and the standard aneurysmal subarachnoid treatment pathway.
Drug: placebo
Within 24 hours after randomization, patients will receive a placebo twice daily (BID) for 14 consecutive days, in addition to the standard aSAH treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delayed cerebral ischemia (DCI)
Time Frame: At 14±2 days after randomization
Delayed cerebral ischemia (DCI) was defined as the occurrence of clinical deterioration, including new-onset focal neurological deficits (e.g., hemiplegia, aphasia, apraxia, hemianopia, or neglect) and/or a decrease in the consciousness (a Glasgow Coma Scale [GCS] score reduction of at least 2 points, either in the total score or any individual subscore), with symptoms lasting for at least 1 hour and not occurring immediately after aneurysm surgery. Other potential causes of clinical deterioration (e.g., hydrocephalus, rebleeding, fever, infection, metabolic disturbance, epilepsy, etc.) were excluded. Alternatively, DCI was defined as the presence of new infarct lesions on follow-up brain CT/MRI that were not detected on the initial admission brain CT or post-operative follow-up brain CT.
At 14±2 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological function prognosis
Time Frame: At 90 days after randomization
The modified Rankin Scale (mRS) score and Glasgow Outcome Scale (GOS) score were evaluated at 90 days after randomization. Favorable outcome was defined as an mRS score of 0-3 (0-3 indicating no disability to moderate disability; 4-6 indicating moderately severe disability to death) and a GOS score of 3-5 (3-5 indicating severe disability to good recovery).
At 90 days after randomization
Incidence of intracranial rebleeding events
Time Frame: At 90±7 days after randomization
Any new intracranial hemorrhage occurring within 90 days after randomization (whether rebleeding in the surgical area or new intracranial hemorrhage events following cilostazol administration), confirmed by comparing non-contrast CT scan results during follow-up with those of the last post-operative non-contrast CT scan before randomization.
At 90±7 days after randomization
Incidence of other severe bleeding events
Time Frame: At 90 days after randomization
Any new symptomatic intracranial hemorrhage or any new moderate or severe hemorrhage occurring within 90 days after randomization (defined according to the Bleeding Academic Research Consortium [BARC] criteria as hemorrhage requiring endoscopic treatment, surgical intervention, or blood transfusion [Types 2-3] and fatal hemorrhage [Type 5]).
At 90 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPTAIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available. Sharing IPD will require IRB approval from Tiantan Hospital and other participating institutes in China.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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