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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.
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 4ËšC. 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 4ËšC. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin 10 mg | Experimental | Simvastatin 10 mg |
|
| Simvastatin 40 mg | Experimental | Simvastatin 40 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| neurological outcomes by measuring National Institutes of Health Stroke Scale (NIHSS) | NIHSS is a assessment of clinical neurology in stroke | 180 days |
| neurological outcomes by modified Rankin's Scale (mRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sombat Muengtaweepongsa, M.D. | Faculty of Medicine, Thammasat University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29850244 | Derived | 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. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| C012211 | ubenimex |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| 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. |
|
|
mRS is a assessment of clinical neurology in stroke
| 180 days |
| neurological outcomes by measuring Barthel's index | Barthel's index is a assessment of clinical neurology in stroke | 180 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |