None listed
Conditions
Interventions
Drug : The subjects are stratified by LDL-C levels (<100 mg /dL and =100 mg /dL) at baseline lipid tests and then randomized using stratified block randomization.
Thus, subjects will be randomly assi
Sponsors
Inje University Ilsan Paik Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with recent ischemic stroke who meet both 1) and 2) criteria below. 1) Patients with acute ischemic stroke confirmed by DWI(diffusion-weighted image) This is satisfied by meeting at least one of the following two criteria: A) Patients who sustained stroke symptoms for more than 24 hours and had acute ischemic lesions on DWI. B) Patients with acute ischemic lesions in DWI who had improved symptoms within 24 hours. 2) Patients with ischemic stroke within 90 days. 2. Statin therapy indicated according to the recommendations of the 2014 American Heart Association/American Stroke Association guidelines. This is accomplished by meeting at least one of the following three criteria: A) Patients with ischemic stroke due to arteriosclerosis and LDL-C = 100 mg / dL. (Class I; Level of Evidence B) B) Patients with ischemic stroke due to arteriosclerosis and LDL-C <100 mg / dL. (Class I; Level of Evidence C) C) Patients who require statin therapy due to other associated atherosclerotic cardiovascular disease. (Class I; Level of Evidence A). 3. Patients without statin dose within 28 days before ischemic stroke. 4. Patients who measured baseline LDL-C levels after an ischemic stroke. This is satisfied by meeting at least one of the following two criteria: A) Patients who had a baseline LDL-C level before the onset of a recent ischemic stroke and started statin therapy. B) Patients hospitalized with acute ischemic stroke who had baseline LDL-C levels after initiation of statin therapy should meet both of the following conditions: (1) Patients with LDL-C levels measured within 3 days after initiation of statin therapy (2) Patients in whom randomization and administration of the study drug can be administered within 7 days after baseline LDL-C measurement. 5. Adults over 19 years. 6. Those who voluntarily agreed in writing to the trial.
Exclusion criteria
Exclusion criteria: 1. Planned vascular intervention before the end of trial 2. Significant hepatic dysfunction (AST or ALT >120 IU/L) 3. Allergy or contraindication to rosuvastatin or ezetimibe 4. Alcohol or drug addiction 5. Pregnancy or breast-feeding 6. Severe anemia: Hb level 1·7 8. Inability or unwillingness to comply with study-related procedures 9. Employees of the investigator or study center, with direct involvement in the current study 10. Women unwilling to continue contraception during the study period 11. Participation in other clinical trials within three-month 12. Malignancy or other serious medical conditions with a life expectancy <6 months 13. Treatment with protease inhibitors or cyclosporine 14. Other reasons for ineligibility judged by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with LDL-C decreased more than 50% at 90 days(±14 days) compared to Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with LDL-C less than 70 mg/dL at 90 days(±14 days);The percentage of subjects with LDL-C decreased more than 50% or less than 70 mg/dL at 90 days(±14 days);The decrement of LDL-C at 90 days (± 14 days) compared to baseline LDL-C (absolute difference and % change);The percentage of subjects achieved multiple lipid level (Total-C < 200mg/dL, LDL-C < 70mg/dL and triglyceride < 150 mg /dL);Cardiovascular event rates including stroke (ischemic of hemorrhagic), coronary artery(myocardial infarction or coronary vascular reperfusion) and death related to vascular disease.;Death events of all causes.;New diabetes.;Fatigue of subjects measured by Fatigue Severity Scale.;Incidence of rhabdomyolysis;Incidence of serious liver dysfunction.(AST or ALT increased more than three times from baseline level) | — |
Countries
Korea, Republic of
Contacts
Public ContactKeun-Sik Hong
Inje University Ilsan Paik Hospital
Outcome results
None listed