Efficacy of High and Low-Dose Simvastatin on Vascular Oxidative Stress and Neurological Outcome in Patients With AIS
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with acute ischemic stroke will be divided into 2 groups by double-blind,
      randomized, and controlled trial. Personality and past history of the patients will be
      recorded after the patients signed inform consent. The patient will be collected blood among
      10 cc. for measurement biomarker in serum that related plaque stability for baseline and
      obtained neurological examination for baseline.

      The patients must be take pills for 180 days by randomized code number on pill box, and
      patients must be turn into the site for follow up visit at Day 90 and Day 180. All visits of
      the patients will be collected blood among 10 cc. for measurement biomarker in serum that
      related plaque stability and obtained neurological examination.

      Next, the data will be separated with code number for divided group into 2 groups. Group 1 is
      simvastatin 10 mg per day treatment (n=36) and Group 2 is simvastatin 40 mg per day
      treatment. Finally, all data of each group will be calculated mean ± standard deviation, and
      compared by statistical analysis.
    

Detailed description: 
      Patients with acute ischemic stroke will be divided into 2 groups by double-blind,
      randomized, and controlled trial. Personality and past history of the patients will be
      recorded after the patients signed inform consent. The patient will be collected blood among
      10 cc. for measurement biomarker in serum that related plaque stability i.e. sLOX-1 and NO
      levels for baseline and obtained neurological examination i.e. NIHSS, mRS and Barthel's index
      scale for baseline. The bloods will be centrifuged 4,000 rpm for 15 minutes at 4˚C. The
      supernatant will be collected for determine sLOX-1 and NO levels by ELIZA.

      The patients must be take pills for 180 days by randomized code number on pill box, and
      patients must be turn into the site for follow up visit at Day 90 and Day 180. All visits of
      the patients will be collected blood among 10 cc. for measurement biomarker in serum that
      related plaque stability i.e. sLOX-1 and NO, and obtained neurological examination i.e.
      NIHSS, mRS and Barthel's index scale. The bloods were centrifuged 4,000 rpm for 15 minutes at
      4˚C. The supernatant were collected for determine all biomarkers by ELIZA.

      Next, the data will be separated with code number for divided group into 2 groups. Group 1 is
      simvastatin 10 mg per day treatment (n=36) and Group 2 is simvastatin 40 mg per day treatment
      (n=36) . Finally, all data of each group will be calculated mean ± standard deviation, and
      compared by statistical analysis.
    

Intervention name(s): Simvastatin 10 mg; Simvastatin 40 mg
Intervention type(s): Drug; Drug
Intervention description(s): Simvastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.
Simvastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.; Simvastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.
Simvastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.
Other intervention name(s): Bestatin; Bestatin
Intervention MeSH terms: Ubenimex; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Simvastatin; Plaque stability; Acute ischemic stroke