Using sodium valproate to treat acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial aims to evaluate the feasibility, safety, and efficacy of sodium valproate in patients suffering from acute ischemic stroke. The study will investigate whether sodium valproate can enhance peripheral anti-inflammatory CD177+ neutrophil levels, which may contribute to its neuroprotective effects. Participants will be treated with sodium valproate or normal saline within 24 hours of stroke onset, and the study will help inform the design of future larger trials. The research is significant due to the limited effective treatment options currently available for ischemic stroke.

Why it matters

Who can join: the full rules

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.

Where it's running

• Renji Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai, China Recruiting

Study contacts

• Principal investigator: Peiying Li, Doctor — RenJi Hospital
• Study coordinator: Peiying Li, Doctor
• Email: peiyingli.md@gmail.com
• Phone: +8615800616866

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Mobilisation After Endovascular Stroke Treatment

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• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.