Sodium Valproate in Patients With Acute Ischemic Stroke

NCT06020898 | Recruiting Phase 2

• 1 other identifier: LY2023-138-A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Sodium valproate; Acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Favorable outcome at 90 days (the Modified Rankin Scale (mRS) score≤2)

  The proportion of patients with favorable outcome, which is defined as the Modified Rankin Scale (mRS) score 0-2.

  Day 90

Secondary Outcomes (4)

• Favorable outcome at 30 days (the Modified Rankin Scale (mRS) score≤2)

  Day 30

• NIH Stroke Scale (NIHSS) score at 3 days

  Day 3

• NIH Stroke Scale (NIHSS) score at 7 days

  Day 7

• Changes of lesion volume from baseline to day 7

  Day 7

Other Outcomes (2)

• The peripheral CD177+ neutrophil levels

  Day 3 and Day 7

• The levels of inflammatory cytokines in peripheral blood

  Day 3 and Day 7

Study Arms (2)

Sodium valproate group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

Within 3 days after admission, normal saline will be given daily in the same way.

Drug: Normal saline

Interventions

Sodium valproate DRUG

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.

Sodium valproate group

Normal saline DRUG

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 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• mRS ≥ 2 before the disease onset;
• Refractory hypertension (SBP\>180mmHg or DBP\>110mmHg after antihypertensive treatment);
• History of cerebral hemorrhage, intracranial tumor, cerebral arteriovenous malformation and aneurysm;
• History of brain trauma, intracranial or spinal surgery within 3 months, major surgery or severe physical trauma within 1 month;
• Signs of infection at time of admission;
• History of malignancy or active autoimmune disease;
• Use of glucocorticoids or other immunosuppressive medications;
• 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;
• Use of medications containing active ingredients that can be converted to valproic acid, including sodium divalproate and valproamide;
• Contraindications or intolerance for CT perfusion imaging;
• Participating in other conflicting clinical trials;
• Any other condition that investigators consider unsuitable such as mental illness, cognitive impairment, or inability to follow trial procedures.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Valproic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Peiying Li, Doctor

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Jieqing Wan, Doctor

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peiying Li, Doctor

CONTACT

+8615800616866; peiyingli.md@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: September 1, 2023
• Study Start: September 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

CN (1)