Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage

NCT07249853 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CAPTAIN
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

Aneurysmal Subarachnoid Hemorrhage; Cilostazol; Delayed Cerebral Ischemia

Outcome Measures

Primary Outcomes (1)

• Incidence of delayed cerebral ischemia (DCI)

  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 Outcomes (3)

• Neurological function prognosis

  At 90 days after randomization

• Incidence of intracranial rebleeding events

  At 90±7 days after randomization

• Incidence of other severe bleeding events

  At 90 days after randomization

Study Arms (2)

Cilostazol Group

EXPERIMENTAL

Administer 100 mg cilostazol, twice daily for 14 days and the standard aneurysmal subarachnoid treatment pathway.

Drug: Cilostazol 100 mg BID

Control Group

PLACEBO COMPARATOR

Implement placebo 100mg twice daily for 14 days and the standard aneurysmal subarachnoid treatment pathway.

Drug: placebo

Interventions

Cilostazol 100 mg BID DRUG

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.

Cilostazol Group

placebo DRUG

Within 24 hours after randomization, patients will receive a placebo twice daily (BID) for 14 consecutive days, in addition to the standard aSAH treatment.

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:

• 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)

You may not qualify if:

• Multiple aneurysms (\>1aneurysms confirmed by CTA/DSA)
• Modified Rankin Scale (mRS) score ≥ 3 before onset
• Patients with contraindications to cilostazol use:
• Allergy to cilostazol
• Severe heart failure（New York Heart Association (NYHA) Functional Classification Grade III or IV）
• Coagulation disorders or systemic bleeding (e.g., hemophilia, gastrointestinal bleeding, hemoptysis, etc.)
• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (24)

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  PMID: 21677432 RESULT

• Matsuda N, Naraoka M, Ohkuma H, Shimamura N, Ito K, Asano K, Hasegawa S, Takemura A. Effect of Cilostazol on Cerebral Vasospasm and Outcome in Patients with Aneurysmal Subarachnoid Hemorrhage: A Randomized, Double-Blind, Placebo-Controlled Trial. Cerebrovasc Dis. 2016;42(1-2):97-105. doi: 10.1159/000445509. Epub 2016 Apr 13.

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  PMID: 36450971 RESULT

• Yamaguchi-Okada M, Nishizawa S, Mizutani A, Namba H. Multifaceted effects of selective inhibitor of phosphodiesterase III, cilostazol, for cerebral vasospasm after subarachnoid hemorrhage in a dog model. Cerebrovasc Dis. 2009;28(2):135-42. doi: 10.1159/000223439. Epub 2009 Jun 5.

  PMID: 19506373 RESULT

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• Nishino A, Umegaki M, Fujinaka T, Yoshimine T. Cilostazol attenuates cerebral vasospasm after experimental subarachnoid hemorrhage. Neurol Res. 2010 Oct;32(8):873-8. doi: 10.1179/016164109X12608733393791. Epub 2010 Mar 26.

  PMID: 20350366 RESULT

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  PMID: 28004163 RESULT

• Kherallah RY, Khawaja M, Olson M, Angiolillo D, Birnbaum Y. Cilostazol: a Review of Basic Mechanisms and Clinical Uses. Cardiovasc Drugs Ther. 2022 Aug;36(4):777-792. doi: 10.1007/s10557-021-07187-x. Epub 2021 Apr 16.

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  PMID: 25358850 RESULT

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MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Cilostazol; BID protein, human

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)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Liping Liu

CONTACT

+86-010-59978328; lipingsister@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to the following treatment groups at a 1:1 ratio: Experimental Group： Within 24 hours after randomization, patients will receive cilostazol 100 mg twice daily for 14 consecutive days, in addition to the standard aSAH treatment. Control Group： Within 24 hours after randomization, patients will receive a placebo twice daily (bid) for 14 consecutive days, in addition to the standard aSAH treatment.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 25, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)