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

NCT03402204 | Completed Phase 3 DMC

• 1 other identifier: MTU-EC-IM-4-019/58
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ischemic Stroke

Keywords

Simvastatin; Plaque stability; Acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• vascular oxidative stress by measuring Soluble lectin-like oxidized low density lipoprotein receptor-1 and Nitric oxide levels

  Soluble lectin-like oxidized low density lipoprotein receptor-1 in microgram/milliliter and Nitric oxide in micromole/liter is biomarkers of vascular oxidative stress.

  180 days

Secondary Outcomes (3)

• neurological outcomes by measuring National Institutes of Health Stroke Scale (NIHSS)

  180 days

• neurological outcomes by modified Rankin's Scale (mRS)

  180 days

• neurological outcomes by measuring Barthel's index

  180 days

Study Arms (2)

Simvastatin 10 mg

EXPERIMENTAL

Simvastatin 10 mg

Drug: Simvastatin 10 mg

Simvastatin 40 mg

EXPERIMENTAL

Simvastatin 40 mg

Drug: Simvastatin 40 mg

Interventions

Simvastatin 10 mg DRUG

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.

Also known as: Bestatin

Simvastatin 10 mg

Simvastatin 40 mg DRUG

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.

Also known as: Bestatin

Simvastatin 40 mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with acute ischemic stroke has symptom onset less than 24 hours.
• Patient has 18 to 85 years old.
• Patient has been obtained describe the study and sign on informed consent.

You may not qualify if:

• Patient has indication for simvastatin or ya-hom-navakote.
• Patient has pre-stroke mRS score more than 1.
• Patient was enrolled in other study within 30 days ago.
• Researchers consider that could be harmed by the participants or have certain conditions that could affect the participation in research, such as last stage of cancer.
• According to medical research suggests that patients unable to cooperate in research or inappropriate in joint research with other causes.
• Conscious level has \>2 scores on question 2 of NIHSS.
• Platelet counts have less than 100,000 cells per cubic milliliter.
• Hematocrit has less than 0.25
• Blood sugar (BS) has less than 60 mg/dl or more than 200 ml/dl or between 200 and 300 mg/dl and treated with diabetes drug until the BS levels have less than 200 mg/dl can include for the project before receive the researched drug.
• Patient with uncontrolled hypertension by measure systolic blood pressure (SBP) has more than 200 mmHg and/or diastolic blood pressure (DBP) has more than 110 mmHg before receive the researched drug or patient that receive aggressive treatment.
• Patient with others stroke or severe head injury within 6 weeks before enrolled to the project.
• Patient is received severe surgery within 14 days before enrolled to the project.
• Patient has seizure with acute ischemic stroke.
• Patient has acute myocardial infarction (AMI) or coronary heart disease (CHD) within 3 weeks before enrolled to the project.
• Patient who receives lower-lipid level drug i.e. Ezetrol, Fenofibrate, Gemfibrosil, and Niacin or statin drugs i.e. Atorvastatin and Pitavastatin.

Sponsors & Collaborators

• Thammasat University: lead

Related Publications (1)

• Uransilp N, Chaiyawatthanananthn P, Muengtaweepongsa S. Efficacy of High-Dose and Low-Dose Simvastatin on Vascular Oxidative Stress and Neurological Outcomes in Patient with Acute Ischemic Stroke: A Randomized, Double-Blind, Parallel, Controlled Trial. Neurol Res Int. 2018 Apr 18;2018:7268924. doi: 10.1155/2018/7268924. eCollection 2018.

  PMID: 29850244 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Simvastatin; ubenimex

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Sombat Muengtaweepongsa, M.D.

  Faculty of Medicine, Thammasat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Medicine

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: January 18, 2018
• Study Start: April 1, 2014
• Primary Completion: October 4, 2014
• Study Completion: December 31, 2015
• Last Updated: August 11, 2020

Record last verified: 2020-08