Patients with cerebral infarction or transient ischemic attack.
Conditions
Interventions
Trade Name: Simvastatin
Pharmaceutical Form: Tablet
Trade Name: Simvastatin
Pharmaceutical Form: Tablet
Trade Name: Simvastatin
Pharmaceutical Form: Tablet
Sponsors
Odense University Hospital, Department of Neurology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to investigate whether simvastatin in 3 different doses can cause peripheral neuropathy after 6 months of treatment assessed by nerve conduction, quantitative sensory testing and quantification of nerve fiber density in the dermo-epidermal transition.;Secondary Objective: Not applicable.;Timepoint(s) of evaluation of this end point: Assessments are made before and after 6 months of treatment.;Primary end point(s): The primary efficacy variable will be nerve fiber density and nerve conduction assessed by the amplitude of the sensory action potential and conduction velocity in the sural nerve, amplitude of motor action potential and conduction velocity of the peroneal nerve and minimal F-wave latency in the tibial nerve. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Other variables are secondary.;Timepoint(s) of evaluation of this end point: Assessments are made before and after 6 months of treatment. | — |
Countries
Denmark
Contacts
Public ContactSøren Hein Sindrup
Odense University Hospital, Department of Neurology
Outcome results
None listed