A randomized clinical trial for the comparison of the efficacy and safety of moderate-intensity rosuvastatin plus ezetimibe versus high-intensity rosuvastatin for target LDL-C goal achievement in patients with recent ischemic stroke
The purpose of this study is to compare the efficiency and safety on the target LDL-C goal achievement between rosuvastatin 10 mg plus ezetimibe 10 mg (rosuvastatin/ezetimibe 10/10 mg) once daily versus rosuvastatin 20 mg once daily in patients with recent ischemic stroke. The target LDL-C goal achievement rate in patients with recent ischemic stroke has not been well studied. In particular, no clinical studies have been conducted comparing the efficacy and safety of low-dose rosuvastatin plus ezetimibe with high-dose rosuvastatin single agent for achieving target LDL-C levels. In this trial, the investigators aim to compare the efficacy of the target LDL-C achievement between rosuvastatin 10 mg plus ezetimibe 10 mg (rosuvastatin/ezetimibe 10/10 mg) and rosuvastatin 20 mg in patients with recent ischemic stroke. For this trial, more than 292 patients (584 total) per group will be enrolled. Subjects who were satisfied with the inclusion/exclusion criteria of this trial and who agreed to participate in the clinical trial in writing were randomly assigned to a 1:1 ratio in the experimental group (the low-dose combination of rosuvastatin plus ezetimibe) and comparator group (high-dose rosuvastatin). The duration of administration of the drug for clinical trials is 90 days (±14 days), and the efficacy and safety evaluation parameters are compared with baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
584
* Rosuvastatin/Ezetimibe 10/10mg * orally administered once daily for 90 days
* Rosuvastatin 20mg * orally administered once daily for 90 days
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea
Hallym University Medical Center
Anyang-si, Gyeonggi-do, South Korea
Myongji Hospital
Goyang-si, Gyeonggi-do, South Korea
The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline
The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline
Time frame: Baseline, Visit 4(Day 90)
Percentage of subjects with LDL-C less than 70 mg/dL at 90 days(±14 days)
Percentage of subjects with LDL-C less than 70 mg/dL at 90 days(±14 days)
Time frame: Baseline, Visit 4(Day 90)
The percentage of subjects with LDL-C decreased more than or less than 70 mg/dL at 90 days(±14 days)
The percentage of subjects with LDL-C decreased more than or less than 70 mg/dL at 90 days(±14 days)
Time frame: Baseline, Visit 4(Day 90)
The decrement of LDL-C at 90 days (±14 days) compared to baseline LDL-C (absolute difference and change)
The decrement of LDL-C at 90 days (±14 days) compared to baseline LDL-C (absolute difference and change)
Time frame: Baseline, Visit 4(Day 90)
The percentage of subjects achieved multiple lipid level (Total-C < 200mg/dL, LDL-C < 70mg/dL and triglyceride < 150mg /dL)
The percentage of subjects achieved multiple lipid level (Total-C \< 200mg/dL, LDL-C \< 70mg/dL and triglyceride \< 150mg /dL)
Time frame: Baseline, Visit 4(Day 90)
Cardiovascular event rates including stroke (ischemic or hemorrhagic), coronary artery(myocardial infarction or coronary vascular reperfusion) and death related to vascular disease.
Cardiovascular event rates including stroke (ischemic of hemorrhagic), coronary artery(myocardial infarction or coronary vascular reperfusion) and death related to vascular disease.
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Inje University Ilsan Paik Hospital
Ilsan, Gyeonggi-do, South Korea
Chung-Ang University Hopital
Seoul, South Korea
Ewha Womans University Seoul hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung-Hee University Medical Center
Seoul, South Korea
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
...and 2 more locations
Time frame: Baseline to Visit 4(up to 90 days)
Number of Death of all causes.
Number of Death of all causes.
Time frame: Baseline to Visit 4(up to 90 days)
Number of subjects with newly diagnosed diabetes.
Number of subjects with newly diagnosed diabetes.
Time frame: Visit 4(Day 90)
Fatigue scale measured by Fatigue Severity Scale.
Fatigue scale measured by Fatigue Severity Scale. (The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activity and lifestyle in patients with a variety of disorders. A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity. The Fatigue Severity Scale scores range from 9 to 63, with higher scores indicating a greater fatigue severity.)
Time frame: Screening, Visit 4(Day 90)
Incidence of rhabdomyolysis
Incidence of rhabdomyolysis
Time frame: Baseline to Visit 4(up to 90 days)
Incidence of serious liver dysfunction
Incidence of serious liver dysfunction (AST or ALT increase more than three times from baseline)
Time frame: Baseline to Visit 4(up to 90 days)