NCT03402204

Efficacy of High and Low-Dose Simvastatin on Vascular Oxidative Stress and Neurological Outcome in Patients With AIS

Efficacy of High-Dose and Low-Dose Simvastatin on Vascular Oxidative Stress and Neurological Outcomes in Patients With Acute Ischemic Stroke: A Randomized, Double-Blind, Parallel, Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Thammasat University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Simvastatin 10 mg	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.
DRUG	Simvastatin 40 mg	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.

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-10-04
• Completion: 2015-12-31
• First posted: 2018-01-18
• Last updated: 2020-08-11