drugset / Trial / NCT03402204

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

NCT03402204

Phase 3 Completed 64 enrolled Thammasat University
RandomizedParallel-groupDouble-blindBasic science

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.

Timeline

Start
2014-04-01
Primary completion
2014-10-04
Completion
2015-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 10 mg
Subject Simvastatin Small molecule 40 mg

Indications