Cholesterol-lowering treatment and neuropathy

Phase 1

• Conditions: Patients with cerebral infarction or transient ischemic attack.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-000348-14-DK
• Lead Sponsor: Odense University Hospital, Department of Neurology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-27
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

- Admitted to Odense University Hospital at the Department of Neurology or the Common Emergency Department at Neurology level.
- Age: 40-80 years.
- Newly diagnosed cerebral infarction or transient ischemic attack from clinical point of view and / or CT / MRI verification.
For the treatment group applies:
- In relation to the infarction the patients are in need of preventive statin therapy according to the guidelines of the department.
For the control group applies:
- In relation to the infarction the patients are not in need of preventive statin therapy according to the guidelines of the department or the patient does not want treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

- Previous or current treatment with statins ( simvastatin , atorvastatin, rosuvastatin , fluvastatin , lovastatin and pravastatin ) .
- Contraindications against statin therapy .
- Current or previous treatment with drugs with known neurotoxic effects.
- Current or previous co-morbidities that may cause polyneuropathy such as diabetes mellitus , cancer, disease , AIDP , CIDP , connective tissue diseases (ex. Sjogren 's syndrome, SLE , etc. . ), Vitamin B12 deficiency , hypothyroidism, myelomatosis , alcohol overuse (> 21 units for men and 14 units for women respectively per week ) , etc. . Furthermore patients who are being investigated for the same are being excluded.
- Pre-existing peripheral neuropathy diagnose or symptoms suggestive of peripheral neuropathy
- Patients with hypertriglyceridemia (> 10 mmol / l) .
- Bilateral symptomatic cerebral infarcts , where one or both extremities are involved bilaterally , or other neurological disease which obviously will lead to sources of error in assessment with neuropathy rating scales.
- High NIHSS if it is expected to result in a lasting , severe functional impact.
- Aphasia , which makes an adequate information base for consent impossible.
- Other neuropsychological sequelae than aphasia that makes the patient incapable of understanding the given information sufficiently.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified