Sodium Valproate in Patients With Acute Ischemic Stroke

Phase 2

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Normal saline; Drug: Sodium valproate

• Registration Number: NCT06020898
• Lead Sponsor: RenJi Hospital

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.

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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-26
• Study Start: 2023-09-01
• Study First Posted: 2023-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Normal saline	Within 3 days after admission, normal saline will be given daily in the same way.
Sodium valproate group	Sodium valproate	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.

Primary Outcome Measures

Name	Time	Method
Favorable outcome at 90 days (the Modified Rankin Scale (mRS) score≤2)	Day 90	The proportion of patients with favorable outcome, which is defined as the Modified Rankin Scale (mRS) score 0-2.

Secondary Outcome Measures

Name	Time	Method
Favorable outcome at 30 days (the Modified Rankin Scale (mRS) score≤2)	Day 30	The proportion of patients with favorable outcome, which is defined as the Modified Rankin Scale (mRS) score 0-2.
NIH Stroke Scale (NIHSS) score at 3 days	Day 3	The NIH Stroke Scale (NIHSS) score ranges from 0 to 42, where high scores mean a worse outcome.
NIH Stroke Scale (NIHSS) score at 7 days	Day 7	The NIH Stroke Scale (NIHSS) score ranges from 0 to 42, where high scores mean a worse outcome.
Changes of lesion volume from baseline to day 7	Day 7	The infarct lesion volume will be measures on magnetic resonance imaging DWI and FLAIR.

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China