Status:
COMPLETED
Efficacy of High and Low-Dose Simvastatin on Vascular Oxidative Stress and Neurological Outcome in Patients With AIS
Lead Sponsor:
Thammasat University
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 si...
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 si...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2015
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03402204
Start Date
April 1 2014
End Date
December 31 2015
Last Update
August 11 2020
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