Comparison of the efficacy and safety of moderate-intensity rosuvastatin plus ezetimibe versus high-intensity rosuvastatin for target low-density lipoprotein goal achievement in patients with recent ischemic stroke
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0003890
- Lead Sponsor
- Inje University Ilsan Paik Hospital
- Brief Summary
Of 584 randomized, 530 were included in the modified intention-to-treat analysis. The primary endpoint of LDL-C reduction =50% from baseline was achieved in 198 patients (72.5%) in the ROS10/EZT10 group and 148 (57.6%) in the ROS20 group of the modified ITT population, and the difference was significant (odds ratio [95% confidence interval], 1.944 [1.352–2.795]; p=0.0003) In this randomized trial, we found that the combination of moderate-intensity rosuvastatin 10 mg plus ezetimibe 10 mg was superior to high-intensity rosuvastatin 20 mg alone for LDL-C reduction in patients with recent ischemic stroke who initiated lipid-lowering therapy. The adverse event rates did not differ between the 2 groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 584
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.
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 <10 g/dL for men and <9 g/dL for women
7. Bleeding diathesis: platelet count <100,000/µl or PT INR > 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of subjects with LDL-C decreased more than 50% at 90 days(±14 days) compared to Baseline
- Secondary Outcome Measures
Name Time Method 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)