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Safety and efficacy of atorvastatin in the treatment of spinal cord injury

Safety and efficacy of atorvastatin in the treatment of spinal cord injury

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079403
Enrollment
Unknown
Registered
2024-01-02
Start date
2024-01-31
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal cord injury

Interventions

Atorvastatin treatment group:Atorvastatin treatment
control:placebo

Sponsors

First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old; 2. The axonal integrity of ASIA grade A injury was identified by DTI; 3. ASIA Grade B-D injury of spinal cord injury; 4. The injured parts of the carina are neck segment, chest segment or waist segment; 5. Within 18h after admission; 6. Able to complete standardized neurological examination according to ISNCSCI standards (including patients using ventilators) willing and able to participate in the follow-up of this study; 7. MRI scan of the injured area excluded tumors, tuberculosis and other lesions; 8. Women who are fertile must have a negative serum beta-HCG pregnancy test or a negative urine pregnancy test.

Exclusion criteria

Exclusion criteria: 1. Severe opportunistic infection or opportunistic tumor; 2. Abnormal blood routine examination (white blood cells < 3×109/L, hemoglobin < 90g/L, neutrophils < 1.5×109/L, platelets < 75×109/L); 3. Have definite liver disease (hepatitis B surface antigen /HCV antibody positive), or abnormal liver function tests (alanine aminotransferase and/or ASpartate aminotransferase exceeding 3 times the upper limit of normal, or total bilirubin exceeding 2 times the upper limit of normal); 4. Renal insufficiency (glomerular filtration rate < 70ml/min or creatinine exceeding the upper limit of normal); 5. Currently suffering from more serious chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric diseases and neurotransmitter-related diseases (such as epilepsy, Parkinson's disease, etc.), active bleeding, severe hypertension, severe thrombocytopenia, hyperkalemia; 6. Neurological damage caused by other tissues and organs; 7. Severe head injury as defined by the Glasgow Coma Scale score =14 was associated with head CT showing clinically significant abnormalities (only patients with suspected brain injury were considered by the investigators to need head CT); 8. Participated in a clinical trial of another investigational drug or device within the past 30 days; 9. Allergic to atorvastatin or any of its components.

Design outcomes

Primary

MeasureTime frame
AISA;

Secondary

MeasureTime frame
SEP and MEP;

Countries

China

Contacts

Public ContactGuoyong Yin

The First Affiliated Hospital of Nanjing Medical University

guoyong_yin@sina.com+86 136 7518 5445

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026