Status:
RECRUITING
Sodium Valproate in Patients With Acute Ischemic Stroke
Lead Sponsor:
RenJi Hospital
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 in...
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 strok...
Eligibility Criteria
Inclusion
- 18≤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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06020898
Start Date
September 1 2023
End Date
April 30 2024
Last Update
February 21 2024
Active Locations (1)
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1
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127