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Aneurysmal Subarachnoid HemorrhageNCT06329635

Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial

A study testing Intrathecal Nicardipine in people with Aneurysmal Subarachnoid Hemorrhage and Vasospasm, run by The Affiliated Hospital Of Guizhou Medical University at 28 sites 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
Search all trials

Trial summary

To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Aneurysmal Subarachnoid Hemorrhage, Vasospasm
What is being tested?
Intrathecal Nicardipine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
396 participants
Where
28 sitesChina
Study dates
27 May 2024to May 2026
Phase
Interventional
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

  • Age 18-80.
  • Spontaneous SAH confirmed by head CT.
  • Saccular brain aneurysm is identified and treated, either surgically or endovascularly.
  • SAH Fisher grade >1 or modified Fisher grade >0.
  • EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemed necessary by the treating physician.
  • Any clinical scenario leading to the diagnosis of possible vasospasm, which includes:
Show all 12Show fewer
  • Mean flow velocity of MCA >120, or Lindegaard Ratio ( LR ) > 3.
  • Any intracranial artery including MCA, ACA, PCA, and BA, TCD showed an upward trend of mean flow velocity for 2 consecutive days (>25cm/s/day).
  • Clinical deterioration including mental status change (GCS score decrease > 2) and focal neurological deficit unable to be attributed to other known neurological reasons.
  • Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI.
  • Within 14 days of onset of SAH.
  • Informed consent obtained from the patient or family member.

Who cannot join

  • Hunt-Hess Grade 5 or WFNS Grade 5 (no clinical improvement after EVD placement for acute hydrocephalus).
  • Bacterial or distal aneurysms without subarachnoid hemorrhage in the basal cisterns.
  • The treating physician determines that the culprit aneurysm has not been fully repaired, with a very high likelihood of rebleeding in the near term.
  • History of head trauma within the past 3 months.
  • Any recent brain disease within 3 months, such as tumors, stroke, epilepsy, vasculitis, arteriovenous malformation, hydrocephalus, etc.
  • History of psychiatric disorders or seizures within 3 months.
Show all 12Show fewer
  • Severe concurrent medical conditions.
  • Pregnant women or those of childbearing potential with a positive urine or serum β-human chorionic gonadotropin (HCG) test.
  • Lactating women.
  • Life expectancy of less than 1 year prior to aSAH onset.
  • Pre-morbid mRS score >1.
  • Participation in another randomized clinical trial that may confound the evaluation of this study.

Trial locations and contacts

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

Guangtang Chen, MD contact

+8618286089635

18286089635@163.com

28 sites in 1 country

China28 sites, 28 recruiting

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 014040

    Shijun Zhao, MD, 18047209336, zhaoshijun1981@163.com

    Recruiting

  • Beijing Tiantan Hospital, Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100070

    Xiaolin Chen

    Recruiting

  • Changzhou First People's Hospital

    Changzhou, Jiangsu, 213004

    Ya Peng

    Recruiting

  • West China Airport Hospital of Sichuan University

    Chengdu, Sichuan, 610299

    Jun Lei

    Recruiting

  • Chongqing Ninth People's Hospital

    Chongqing, Chongqing Municipality, 400799

    Yi Huang

    Recruiting

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi, 341000

    Qiuhua Jiang

    Recruiting

  • Southern Medical University Zhujiang Hospital

    Guangzhou, Guangdong, 510260

    Chuanzhi Duan

    Recruiting

  • Jinyang Hospital Affiliated to Guizhou Medical University

    Guiyang, Guizhou, 550080

    Qing Xiao

    Recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Jianwei Pan

    Recruiting

  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310007

    Shu Wan

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Jianmin Zhang

    Recruiting

  • Affiliated First Hospital of Anhui Medical University

    Hefei, Anhui, 230000

    Jing Luo

    Recruiting

  • Jinggangshan University Affiliated Hospital

    Ji’an, Jiangxi, 343099

    Yongcheng Zhang

    Recruiting

  • The Second Affiliated Hospital of Guizhou Medical University

    Kaili, Guizhou, 556099

    Yong Ni

    Recruiting

  • Qianfengdong Prefecture People's Hospital

    Kaili, G, 556099

    Jian Shen

    Recruiting

  • Liupanshui City People's Hospital

    Liupanshui, Guizhou, 553400

    Yi Ding

    Recruiting

  • Western Medical University Affiliated Hospital

    Luzhou, Sichuan, 646099

    Jianhua Peng

    Recruiting

  • Nanning First People's Hospital

    Nanning, Guangxi, 530016

    Feng Wei

    Recruiting

  • Nanyang Central Hospital, Henan Province

    Nanyang, Henan, 473005

    Shuai Dang

    Recruiting

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 201112

    Bing Zhao

    Recruiting

  • Affiliated South China Hospital of Shenzhen University

    Shenzhen, Guangdong, 518111

    Shihui, Du

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 230601

    Jianliang Wu

    Recruiting

  • Taian Central Hospital, Shandong Province

    Tai’an, Shandong, 27109

    Xiao Chen

    Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Geng Guo

    Recruiting

  • People's Hospital of Qiannan Buyi and Miao Autonomous Prefecture, Guizhou Province

    Xingyi, Guizhou, 558000

    Yingwen Huang

    Recruiting

  • Qianxinan Prefecture People's Hospital

    Xingyi, Guizhou, 562499

    Shiqiang Wang

    Recruiting

  • Xingyi City People's Hospital

    Xingyi, Guizhou, 562499

    Ming Gong

    Recruiting

  • The First People's Hospital of Zhenjiang City, Jiangsu Province

    Zhenjiang, Jiangsu, 212002

    Bo Chen

    Recruiting

Other trials in China

About this study

Official title: Trial of Treatment of Vasospasm Associated With Aneurysmal Subarachnoid Hemorrhage With Intrathecal Injection of Nicardipine: a Multi-center, Prospective, Double-blinded, Randomized Controlled Trial

To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.

Read the detailed description

Objective:

To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.

Design:

This study is a multi-center, prospective, double-blinded, randomized controlled trial.

Interventions:

First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride solution (NaCl), and then the EVD or LD tube was clamped for 2 hours after the injection was completed, then kept open as clinically necessary until the next dose (twice a day).

Being tested
Intrathecal Nicardipine, No intervention
Keywords
Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Delayed cerebral ischemia, Nicardipine, Intrathecal injection
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

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

  • Intrathecal NicardipineDrug

    Also called Treatment group

    First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml (4mg) of nicardipine is injected into the EVD or LD drain tube, followed by 2 ml normal saline solution, and then the EVD or LD tube is clamped for 2 hours, and then kept open as clinically necessary until the next dose (q12h) of medication.

  • No interventionOther

    Also called Blank control group

    A simulated "intrathecal administration" operation is performed by a dedicated physician who is unblinded to the group assignment, the EVD or LD tube is not opened, and no "drug" is given. The simulated administration process needs to be out of the patient's view (if awake patient) and out of the presence of study team personnel.

Study groups in NCT06329635
Study groupRoleWhat they receive
Intrathecal Treatment GroupExperimentalThe participants in the IT treatment group will be treated with intrathecal nicardipine injection through EVD or LP draining catheter.
Receives: Drug: Intrathecal Nicardipine
Control GroupSham comparatorThe participants of the control group will receive no intrathecal nicardipine injection through EVD or LP draining catheter.
Receives: Other: No intervention

What is being measured

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

  1. Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6

    The percentage of patients with mRS 0-2

    Measured: Day 90±30, Day 365±60.

Secondary outcomes (11)

  1. Extended Glasgow Outcome Score (GOS-E).

    Minimum score 1 and maximum score 8 with higher number being better outcome

    Measured: Day 90±30, Day 365±60.

  2. Modified Rankin Scale ordinal shift with mRS 5 and 6 combined

    Shift analysis looks at transitions across different levels of mRS score, shifting from higher score to lower score means favorable outcome

    Measured: Day 90±30, Day 365±60.

  3. Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6

    The percentage of patients with mRS 0-3

    Measured: Day 90±30, Day 365±60.

  4. Mini-Mental State Examination (MMSE) score

    Minimum score 0 and maximum score 30 with higher score being better outcome

    Measured: Day 90±30, Day 365±60.

  5. Change of National Institutes of Health Stroke Scale (NIHSS) score

    NIHSS Scores range from 0 - 42 with higher score being worse outcome

    Measured: At discharge

  6. Cerebrospinal fluid shunt surgery rate

    The incidence of CSF shunt surgery

    Measured: Day 90±30, Day 365±60.

  7. Overall mortality rate

    All etiology of mortality

    Measured: Day 90±30, Day 365±60.

  8. Rate of CSF infection

    Diagnosed with fever, positive CSF test including culture.

    Measured: Day 30±7

  9. Rate of any type of new intracranial hemorrhage.

    The incidence of CSF shunt surgery

    Measured: Day 90±30, Day 365±60.

  10. Adverse Event

    From enrollment to the end of the study, any event meeting the definition of adverse event (AE) was defined as an adverse event, and each occurrence was recorded in a separate adverse event table.

    Measured: Baseline, Day 2-21, Day 90±30, Day 365±60.

  11. Serious Adverse Event

    During the period from enrollment to the end of the study, any event meeting the definition of serious adverse event (SAE) was defined as serious adverse event, and each occurrence was recorded by a separate adverse event table.

    Measured: Baseline, Day 2-21, Day 90±30, Day 365±60.

Timeline

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

  1. First posted26 Mar 2024
  2. Study start27 May 2024
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06329635
Sponsor's protocol ID
2023070K
Status last verified
Sep 2025
First submitted
19 Mar 2024
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wartenberg KE, Schmidt JM, Claassen J, Temes RE, Frontera JA, Ostapkovich N, Parra A, Connolly ES, Mayer SA. Impact of medical complications on outcome after subarachnoid hemorrhage. Crit Care Med. 2006 Mar;34(3):617-23; quiz 624. doi: 10.1097/01.ccm.0000201903.46435.35.

    PubMed 16521258

  • Al-Khindi T, Macdonald RL, Schweizer TA. Cognitive and functional outcome after aneurysmal subarachnoid hemorrhage. Stroke. 2010 Aug;41(8):e519-36. doi: 10.1161/STROKEAHA.110.581975. Epub 2010 Jul 1.

    PubMed 20595669

  • Vergouwen MD; Participants in the International Multi-Disciplinary Consensus Conference on the Critical Care Management of Subarachnoid Hemorrhage. Vasospasm versus delayed cerebral ischemia as an outcome event in clinical trials and observational studies. Neurocrit Care. 2011 Sep;15(2):308-11. doi: 10.1007/s12028-011-9586-8.

    PubMed 21748502

  • Macdonald RL, Hunsche E, Schuler R, Wlodarczyk J, Mayer SA. Quality of life and healthcare resource use associated with angiographic vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2012 Apr;43(4):1082-8. doi: 10.1161/STROKEAHA.111.634071. Epub 2012 Feb 9.

    PubMed 22328549

  • Springer MV, Schmidt JM, Wartenberg KE, Frontera JA, Badjatia N, Mayer SA. Predictors of global cognitive impairment 1 year after subarachnoid hemorrhage. Neurosurgery. 2009 Dec;65(6):1043-50; discussion 1050-1. doi: 10.1227/01.NEU.0000359317.15269.20.

    PubMed 19934963

  • Pegoli M, Mandrekar J, Rabinstein AA, Lanzino G. Predictors of excellent functional outcome in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2015 Feb;122(2):414-8. doi: 10.3171/2014.10.JNS14290. Epub 2014 Dec 12.

    PubMed 25495745

  • Frontera JA, Fernandez A, Schmidt JM, Claassen J, Wartenberg KE, Badjatia N, Connolly ES, Mayer SA. Defining vasospasm after subarachnoid hemorrhage: what is the most clinically relevant definition? Stroke. 2009 Jun;40(6):1963-8. doi: 10.1161/STROKEAHA.108.544700. Epub 2009 Apr 9.

    PubMed 19359629

  • Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, Muizelaar JP, Mendelow AD, Juvela S, Yonas H, Terbrugge KG, Macdonald RL, Diringer MN, Broderick JP, Dreier JP, Roos YB. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke. 2010 Oct;41(10):2391-5. doi: 10.1161/STROKEAHA.110.589275. Epub 2010 Aug 26.

    PubMed 20798370

  • Grossen AA, Ernst GL, Bauer AM. Update on intrathecal management of cerebral vasospasm: a systematic review and meta-analysis. Neurosurg Focus. 2022 Mar;52(3):E10. doi: 10.3171/2021.12.FOCUS21629.

    PubMed 35231885

  • Fisher CM, Kistler JP, Davis JM. Relation of cerebral vasospasm to subarachnoid hemorrhage visualized by computerized tomographic scanning. Neurosurgery. 1980 Jan;6(1):1-9. doi: 10.1227/00006123-198001000-00001.

    PubMed 7354892

  • Reilly C, Amidei C, Tolentino J, Jahromi BS, Macdonald RL. Clot volume and clearance rate as independent predictors of vasospasm after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2004 Aug;101(2):255-61. doi: 10.3171/jns.2004.101.2.0255.

    PubMed 15309916

  • Vorkapic P, Bevan JA, Bevan RD. Longitudinal in vivo and in vitro time-course study of chronic cerebrovasospasm in the rabbit basilar artery. Neurosurg Rev. 1991;14(3):215-9. doi: 10.1007/BF00310660.

    PubMed 1944936

  • Al-Mufti F, Amuluru K, Damodara N, El-Ghanem M, Nuoman R, Kamal N, Al-Marsoummi S, Morris NA, Dangayach NS, Mayer SA. Novel management strategies for medically-refractory vasospasm following aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2018 Jul 15;390:44-51. doi: 10.1016/j.jns.2018.02.039. Epub 2018 Feb 23.

    PubMed 29801906

  • Murayama Y, Malisch T, Guglielmi G, Mawad ME, Vinuela F, Duckwiler GR, Gobin YP, Klucznick RP, Martin NA, Frazee J. Incidence of cerebral vasospasm after endovascular treatment of acutely ruptured aneurysms: report on 69 cases. J Neurosurg. 1997 Dec;87(6):830-5. doi: 10.3171/jns.1997.87.6.0830.

    PubMed 9384391

  • Yalamanchili K, Rosenwasser RH, Thomas JE, Liebman K, McMorrow C, Gannon P. Frequency of cerebral vasospasm in patients treated with endovascular occlusion of intracranial aneurysms. AJNR Am J Neuroradiol. 1998 Mar;19(3):553-8.

    PubMed 9541318

Questions about this trial

What is this clinical trial studying?

A study testing Intrathecal Nicardipine in people with Aneurysmal Subarachnoid Hemorrhage and Vasospasm, run by The Affiliated Hospital Of Guizhou Medical University at 28 sites 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 12 inclusion and 12 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites 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.

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 Guangtang Chen, MD (+8618286089635, 18286089635@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6 (time frame: Day 90±30, Day 365±60.). 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 NCT06329635, which also lists 39 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 8 Sep 2025.

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