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

Primary Purpose

Ischemic Stroke

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Simvastatin 10 mg

Simvastatin 40 mg

About this trial

This is an interventional basic science trial for Ischemic Stroke focused on measuring Simvastatin, Plaque stability, Acute ischemic stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Patient has increasing liver enzyme level or liver abnormal disease.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Simvastatin 10 mg

Simvastatin 40 mg

Arm Description

Simvastatin 10 mg

Simvastatin 40 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

NIHSS is a assessment of clinical neurology in stroke

neurological outcomes by modified Rankin's Scale (mRS)

mRS is a assessment of clinical neurology in stroke

neurological outcomes by measuring Barthel's index

Barthel's index is a assessment of clinical neurology in stroke

Full Information

NCT ID

NCT03402204

First Posted

August 14, 2015

Last Updated

August 10, 2020

Sponsor

Thammasat University

1. Study Identification

Unique Protocol Identification Number

NCT03402204

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

April 1, 2014 (Actual)

Primary Completion Date

October 4, 2014 (Actual)

Study Completion Date

December 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thammasat University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

Simvastatin, Plaque stability, Acute ischemic stroke

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin 10 mg

Arm Type

Experimental

Arm Description

Simvastatin 10 mg

Arm Title

Simvastatin 40 mg

Arm Type

Experimental

Arm Description

Simvastatin 40 mg

Intervention Type

Drug

Intervention Name(s)

Simvastatin 10 mg

Other Intervention Name(s)

Bestatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Simvastatin 40 mg

Other Intervention Name(s)

Bestatin

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

180 days

Secondary Outcome Measure Information:

Title

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

Description

NIHSS is a assessment of clinical neurology in stroke

Time Frame

180 days

Title

neurological outcomes by modified Rankin's Scale (mRS)

Description

mRS is a assessment of clinical neurology in stroke

Time Frame

180 days

Title

neurological outcomes by measuring Barthel's index

Description

Barthel's index is a assessment of clinical neurology in stroke

Time Frame

180 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Patient has increasing liver enzyme level or liver abnormal disease.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sombat Muengtaweepongsa, M.D.

Organizational Affiliation

Faculty of Medicine, Thammasat University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

29850244

Citation

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.

Results Reference

derived

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

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