CompletedNCT03402204Updated Aug 11, 2020

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

A Phase 3 interventional study of Simvastatin 10 mg and Simvastatin 40 mg in Ischemic Stroke, sponsored by Thammasat University. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-08-11.

Sponsored by Thammasat University · Phase 3, Interventional, and Basic science

Phase: Phase 3
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study summary

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.

Read the 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 studied

Ischemic Stroke

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Keywords

Simvastatin
Plaque stability
Acute ischemic stroke

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 3
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 64 participants (actual)

Study arms

Experimental
Simvastatin 10 mg
Simvastatin 10 mg
Drug: Simvastatin 10 mg
Experimental
Simvastatin 40 mg
Simvastatin 40 mg
Drug: Simvastatin 40 mg

Interventions

DrugSimvastatin 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.
Also known as: Bestatin
DrugSimvastatin 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.
Also known as: Bestatin

What researchers measure

Primary outcomes

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.
Time frame: 180 days

Secondary outcomes

neurological outcomes by measuring National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a assessment of clinical neurology in stroke
Time frame: 180 days
neurological outcomes by modified Rankin's Scale (mRS)
mRS is a assessment of clinical neurology in stroke
Time frame: 180 days
neurological outcomes by measuring Barthel's index
Barthel's index is a assessment of clinical neurology in stroke
Time frame: 180 days

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 29850244 ↗

Registry details

Key details

Study ID: NCT03402204
Lead sponsor: Thammasat University
Responsible party: Pannawat Chaiyawatthanananthn (Faculty of Medicine, Thammasat University) — Principal investigator
First posted: Jan 18, 2018
Start date: Apr 1, 2014
Primary completion: Oct 4, 2014
Completion: Dec 31, 2015
Last update: Aug 11, 2020

Study contacts

Sombat Muengtaweepongsa, M.D.

principal investigator · Faculty of Medicine, Thammasat University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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