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Aneurysmal Subarachnoid HemorrhagePhase 3CAPTAINNCT07249853

Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage

A Phase 3 study testing Cilostazol 100 mg BID in people with Aneurysmal Subarachnoid Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Aneurysmal Subarachnoid Hemorrhage
What is being tested?
Cilostazol 100 mg BID
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
380 participants
Where
1 siteChina
Study dates
6 Dec 2025to 31 Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

    Liping Liu, +86-010-59978328, lipingsister@gmail.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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 neurological function prognosis at 90±7 days after randomization. Other secondary endpoints include incidence of delayed cerebral ischemia (DCI) in patients with aneurysmal subarachnoid hemorrhage (aSAH) within 14±2 days after randomization, incidence of intracranial rebleeding events within 90±7 days after randomization, and 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 promoting patients' neurological function prognosis and reducing delayed cerebral ischemia (DCI) in patients with aneurysmal subarachnoid hemorrhage (aSAH).

Being tested
Cilostazol 100 mg BID, placebo
Keywords
Aneurysmal Subarachnoid Hemorrhage, Cilostazol, Delayed Cerebral Ischemia
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cilostazol 100 mg BIDDrug

    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.

  • placeboDrug

    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 groups in NCT07249853
Study groupRoleWhat they receive
Cilostazol GroupExperimentalAdminister 100 mg cilostazol, twice daily for 14 days and the standard aneurysmal subarachnoid treatment pathway.
Receives: Drug: Cilostazol 100 mg BID
Control GroupPlacebo comparatorImplement placebo 100mg twice daily for 14 days and the standard aneurysmal subarachnoid treatment pathway.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurological function prognosis

    The modified Rankin Scale (mRS) score was evaluated at 90 days after randomization. A 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).

    Measured: At 90 days after randomization

Secondary outcomes (5)
  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.

    Measured: At 14±2 days after randomization

  2. Neurological function prognosis

    The Glasgow Outcome Scale (GOS) score was evaluated at 90 days after randomization. A favorable outcome was defined as a GOS score of 3-5 (3-5 indicating severe disability to good recovery).

    Measured: At 90 days after randomization

  3. Neurological function prognosis

    90-day mRS distribution

    Measured: At 90 days after randomization

  4. Incidence of intracranial rebleeding events

    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.

    Measured: At 90±7 days after randomization

  5. Incidence of other severe bleeding events

    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]).

    Measured: At 90 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start6 Dec 2025
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07249853
Sponsor's protocol ID
CAPTAIN
Acronym
CAPTAIN
Status last verified
Jul 2026
First submitted
14 Nov 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available. Sharing IPD will require IRB approval from Tiantan Hospital and other participating institutes in China.

Publications

  • SVIN COVID-19 Global SAH Registry. Global impact of the COVID-19 pandemic on subarachnoid haemorrhage hospitalisations, aneurysm treatment and in-hospital mortality: 1-year follow-up. J Neurol Neurosurg Psychiatry. 2022 Jul 28:jnnp-2022-329200. doi: 10.1136/jnnp-2022-329200. Online ahead of print.

    PubMed 35902229
  • Kim BJ, Lee EJ, Kwon SU, Park JH, Kim YJ, Hong KS, Wong LKS, Yu S, Hwang YH, Lee JS, Lee J, Rha JH, Heo SH, Ahn SH, Seo WK, Park JM, Lee JH, Kwon JH, Sohn SI, Jung JM, Navarro JC, Kang DW; PICASSO investigators. Prevention of cardiovascular events in Asian patients with ischaemic stroke at high risk of cerebral haemorrhage (PICASSO): a multicentre, randomised controlled trial. Lancet Neurol. 2018 Jun;17(6):509-518. doi: 10.1016/S1474-4422(18)30128-5.

    PubMed 29778364
  • Suzuki S, Sayama T, Nakamura T, Nishimura H, Ohta M, Inoue T, Mannoji H, Takeshita I. Cilostazol improves outcome after subarachnoid hemorrhage: a preliminary report. Cerebrovasc Dis. 2011;32(1):89-93. doi: 10.1159/000327040. Epub 2011 Jun 11.

    PubMed 21677432
  • 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.

    PubMed 27070952
  • Nakatsuka Y, Kawakita F, Yasuda R, Umeda Y, Toma N, Sakaida H, Suzuki H; , on behalf of the Prospective Registry for Searching Mediators of Neurovascular Events After Aneurysmal Subarachnoid Hemorrhage (pSEED) Group. Preventive effects of cilostazol against the development of shunt-dependent hydrocephalus after subarachnoid hemorrhage. J Neurosurg. 2017 Aug;127(2):319-326. doi: 10.3171/2016.5.JNS152907. Epub 2016 Aug 5.

    PubMed 27494819
  • Sugimoto K, Nomura S, Shirao S, Inoue T, Ishihara H, Kawano R, Kawano A, Oka F, Suehiro E, Sadahiro H, Shinoyama M, Oku T, Maruta Y, Hirayama Y, Hiyoshi K, Kiyohira M, Yoneda H, Okazaki K, Dreier JP, Suzuki M. Cilostazol decreases duration of spreading depolarization and spreading ischemia after aneurysmal subarachnoid hemorrhage. Ann Neurol. 2018 Dec;84(6):873-885. doi: 10.1002/ana.25361. Epub 2018 Nov 29.

    PubMed 30341966
  • Qureshi AI, Akhtar IN, Ma X, Lodhi A, Bhatti I, Beall J, Broderick JP, Cassarly CN, Martin RH, Sharma R, Thakkar M, Suarez JI. Effect of Cilostazol in Animal Models of Cerebral Ischemia and Subarachnoid Hemorrhage: A Systematic Review and Meta-Analysis. Neurocrit Care. 2023 Jun;38(3):698-713. doi: 10.1007/s12028-022-01637-6. Epub 2022 Nov 30.

    PubMed 36450971
  • 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.

    PubMed 19506373
  • Onal MB, Bilginer B, Narin F, Ziyal MI, Soylemezoglu F, Ozgen T. Comparison of intrathecal cilostazol and nimodipine treatments in subarachnoid hemorrhage: an experimental study in rabbits. Acta Neurochir Suppl. 2011;110(Pt 2):43-8. doi: 10.1007/978-3-7091-0356-2_9.

    PubMed 21125444
  • 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.

    PubMed 20350366
  • Boulouis G, Labeyrie MA, Raymond J, et al. Treatment of cerebral vasospasm following aneurysmal subarachnoid haemorrhage: a systematic review and meta-analysis. Eur Radiol. 2017;27(8):3333-3342. doi:10.1007/s00330-016-4702-ySenbokuya N, Kinouchi H, Kanemaru K, et al. Effects of cilostazol on cerebral vasospasm after aneurysmal subarachnoid hemorrhage: A multicenter prospective, randomized, open-label blinded end point trial - Clinical article. J Neurosurg. 2013;118(1):121-130. doi:10.3171/2012.9.JNS12492

  • 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.

    PubMed 33860901
  • Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.

    PubMed 18779447
  • Kim SG, Hong JM, Kim HY, Lee J, Chung PW, Park KY, Kim GM, Lee KH, Chung CS, Bang OY. Ischemic stroke in cancer patients with and without conventional mechanisms: a multicenter study in Korea. Stroke. 2010 Apr;41(4):798-801. doi: 10.1161/STROKEAHA.109.571356. Epub 2010 Feb 11.

    PubMed 20150545
  • Bedenis R, Stewart M, Cleanthis M, Robless P, Mikhailidis DP, Stansby G. Cilostazol for intermittent claudication. Cochrane Database Syst Rev. 2014 Oct 31;2014(10):CD003748. doi: 10.1002/14651858.CD003748.pub4.

    PubMed 25358850

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cilostazol 100 mg BID in people with Aneurysmal Subarachnoid Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liping Liu (+86-010-59978328, lipingsister@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurological function prognosis (time frame: At 90 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07249853, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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