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Sodium Valproate in Patients With Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT06020898
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : February 21, 2024
Sponsor:
Information provided by (Responsible Party):
Peiying Li, RenJi Hospital

Study Description
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Brief Summary:
The purpose of this pilot trial is to investigate the feasibility, safety, and efficacy of sodium valproate in patients with acute ischemic stroke, and also explore the mechanism: whether valproate increases peripheral anti-inflammatory CD177+ neutrophil levels.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Sodium valproate Drug: Normal saline Phase 2

Detailed Description:

Ischemic stroke is one of the leading causes of disability and mortality worldwide, which imposes a huge burden on families and society. Currently, the effective treatment strategies of ischemic stroke are limited. It is of great clinical value and significance to explore effective neuroprotective medications besides reperfusion therapy.

Sodium valproate is widely used in clinical practice, and its safety and tolerability has been confirmed. It is mainly used in the treatment of epilepsy, bipolar disorder, neuropathic pain and other diseases. In recent years, a number of preclinical studies have found that valproic acid has a potential neuroprotective effect in acute ischemic brain injury, which can decrease infarct volume, reduce blood-brain barrier damage, and improve neurological function. However, the neuroprotective mechanism of sodium valproate has not been fully revealed, and there is still a lack of clinical studies to clarify the neuroprotective effect of sodium valproate in patients with ischemic stroke.

The goal of this study is to test whether sodium valproate could become a new therapeutic approach for ischemic stroke. This prospective pilot study is intended to investigate the feasibility, safety, and efficacy of sodium valproate in patients with acute ischemic stroke, thus support the estimate of sample size for a future full trial. In addition, we will test the hypotheses that valproate increases peripheral anti-inflammatory CD177+ neutrophil levels.

Patients with acute ischemic stroke included in the study will be randomly assigned to sodium valproate group (20 mg/kg/d) or saline placebo group. Treatment will be started within 24 hours after stroke onset. The trial drug will be given intravenously for 3 consecutive days. The investigators evaluate whether sodium valproate can improve clinical outcomes and increase peripheral CD177+ neutrophil levels.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sodium Valproate in Patients With Acute Ischemic Stroke: a Pilot Randomized Trial
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sodium valproate group
Within 3 days after admission, 20mg/kg sodium valproate will be given daily. Specifically, 400mg sodium valproate will be infused within 5 minutes, followed by intravenous drip with 1mg/kg/h.
 Drug: Sodium valproate
Patients with acute ischemic stroke included in the study are randomly assigned to low-dose sodium valproate group, high-dose sodium valproate group and placebo group. Besides receiving conventional treatment for stroke, 10mg/kg sodium valproate, 20mg/kg sodium valproate or normal saline were given intravenously for 3 consecutive days, respectively.
Placebo Comparator: Placebo group
Within 3 days after admission, normal saline will be given daily in the same way.
 Drug: Normal saline
Patients with acute ischemic stroke included in the study are randomly assigned to low-dose sodium valproate group, high-dose sodium valproate group and placebo group. Besides receiving conventional treatment for stroke, 10mg/kg sodium valproate, 20mg/kg sodium valproate or normal saline were given intravenously for 3 consecutive days, respectively.


Outcome Measures
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Primary Outcome Measures :
  1. Favorable outcome at 90 days (the Modified Rankin Scale (mRS) score≤2) [ Time Frame: Day 90 ]
    The proportion of patients with favorable outcome, which is defined as the Modified Rankin Scale (mRS) score 0-2.


Secondary Outcome Measures :
  1. Favorable outcome at 30 days (the Modified Rankin Scale (mRS) score≤2) [ Time Frame: Day 30 ]
    The proportion of patients with favorable outcome, which is defined as the Modified Rankin Scale (mRS) score 0-2.

  2. NIH Stroke Scale (NIHSS) score at 3 days [ Time Frame: Day 3 ]
    The NIH Stroke Scale (NIHSS) score ranges from 0 to 42, where high scores mean a worse outcome.

  3. NIH Stroke Scale (NIHSS) score at 7 days [ Time Frame: Day 7 ]
    The NIH Stroke Scale (NIHSS) score ranges from 0 to 42, where high scores mean a worse outcome.

  4. Changes of lesion volume from baseline to day 7 [ Time Frame: Day 7 ]
    The infarct lesion volume will be measures on magnetic resonance imaging DWI and FLAIR.


Other Outcome Measures:
  1. The peripheral CD177+ neutrophil levels [ Time Frame: Day 3 and Day 7 ]
    The CD177+ neutrophil levels in peripheral blood will be evaluated using flow cytometry.

  2. The levels of inflammatory cytokines in peripheral blood [ Time Frame: Day 3 and Day 7 ]
    IL-1β、IL-2、IL-4、IL-5、IL-6、IL-8、IL-10、IL-12、IL-17A、IFN-α、IFN-γ、TNF-α


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18≤age<75 years;
  2. Admitted to hospital within 24 hours after the onset of neurological impairment symptoms consequent to acute ischemic stroke diagnosed by CT or MRI;
  3. Not suitable for thrombolysis and mechanical thrombectomy;
  4. Written informed consent.

Exclusion Criteria:

  1. mRS ≥ 2 before the disease onset;
  2. Refractory hypertension (SBP>180mmHg or DBP>110mmHg after antihypertensive treatment);
  3. History of cerebral hemorrhage, intracranial tumor, cerebral arteriovenous malformation and aneurysm;
  4. History of brain trauma, intracranial or spinal surgery within 3 months, major surgery or severe physical trauma within 1 month;
  5. Signs of infection at time of admission;
  6. History of malignancy or active autoimmune disease;
  7. Use of glucocorticoids or other immunosuppressive medications;
  8. Contraindications to sodium valproate: pregnancy; liver disease or severe hepatic insufficiency (ALT, AST 3 times higher than the upper normal limit); hemorrhagic risk (such as platelet count <100x109/L, APTT≥35s); allergy to sodium valproate, sodium divalproate, or valproamide; hepatic porphyria; combined use of mefloquine; mitochondrial diseases related to POLG mutations; known disorders of the urea cycle;
  9. Use of medications containing active ingredients that can be converted to valproic acid, including sodium divalproate and valproamide;
  10. Contraindications or intolerance for CT perfusion imaging;
  11. Participating in other conflicting clinical trials;
  12. Any other condition that investigators consider unsuitable such as mental illness, cognitive impairment, or inability to follow trial procedures.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020898


Contacts
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Contact: Peiying Li, Doctor +8615800616866 peiyingli.md@gmail.com

Locations
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China, Shanghai
Renji Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: Peiying Li, Doctor    +8615800616866    peiyingli.md@gmail.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: Peiying Li, Doctor RenJi Hospital
Principal Investigator: Jieqing Wan, Doctor RenJi Hospital
More Information
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Responsible Party: Peiying Li, Professor, RenJi Hospital
ClinicalTrials.gov Identifier: NCT06020898    
Other Study ID Numbers: LY2023-138-A
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: February 21, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peiying Li, RenJi Hospital:
Sodium valproate
Acute ischemic stroke
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
 Infarction
Necrosis
Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs