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| Name | Class |
|---|---|
| Ewha Womans University Seoul Hospital | OTHER |
| Severance Hospital | OTHER |
| Korea University Ansan Hospital | OTHER |
| Korea University Guro Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin/Ezetimibe 10/10mg | Experimental | The experimental group is orally administered with rosuvastatin 10 mg plus ezetimibe 10 mg combination once daily for 90 days. |
|
| Rosuvastatin 20mg | Active Comparator | The comparator group is orally administered with rosuvastatin 20 mg single agent once daily for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Rosuvastatin/Ezetimibe 10 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Visit 4(Day 90) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
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Inclusion Criteria:
Patients with recent ischemic stroke who meet both 1) and 2) criteria below. 1) Patients with acute ischemic stroke confirmed by DWI(diffusion-weighted imaging)
This is satisfied by meeting at least one of the following two criteria:
Patients who sustained stroke symptoms for more than 24 hours and had acute ischemic lesions on DWI.
Patients with acute ischemic lesions in DWI who had improved symptoms within 24 hours.
2) Patients with ischemic stroke within 90 days.
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:
Patients without statin dose within 28 days before ischemic stroke.
Patients who measured baseline LDL-C levels after an ischemic stroke. This is satisfied by meeting at least one of the following two criteria:
Patients who had a baseline LDL-C level before the onset of a recent ischemic stroke and started statin therapy.
Patients hospitalized with acute ischemic stroke who had baseline LDL-C levels after initiation of statin therapy should meet both of the following conditions:
Adults over 19 years.
Those who voluntarily agreed in writing to the trial.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keun-Sik Hong, MD., PhD. | Department of Neurology, Inje University Ilsan Paik Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan-si | Gyeonggi-do | South Korea | |||
| Hallym University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37032475 | Result | Hong KS, Bang OY, Park JH, Jung JM, Lee SH, Song TJ, Nam HS, Park HK, Jung KH, Heo SH, Koo J, Yu KH, Park KY, Kim CK, Park HK, Lee J, Lee J, Seo WK. Moderate-Intensity Rosuvastatin Plus Ezetimibe Versus High-Intensity Rosuvastatin for Target Low-Density Lipoprotein Cholesterol Goal Achievement in Patients With Recent Ischemic Stroke: A Randomized Controlled Trial. J Stroke. 2023 May;25(2):242-250. doi: 10.5853/jos.2022.02957. Epub 2023 Apr 11. |
| Label | URL |
|---|---|
| publication | View source |
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| OTHER |
| Myongji Hospital | OTHER |
| Seoul St. Mary's Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
| Chung-Ang University Hospital | OTHER |
| Hallym University Medical Center | OTHER |
| Kyunghee University Medical Center | OTHER |
| Inje University Ilsan Paik Hospital | OTHER |
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| Active Comparator: Rosuvastatin 20mg | Drug |
|
|
|
The percentage of subjects with LDL-C decreased more than or less than 70 mg/dL at 90 days(±14 days) |
| 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) | 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) | 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. | Baseline to Visit 4(up to 90 days) |
| Number of Death of all causes. | Number of Death of all causes. | Baseline to Visit 4(up to 90 days) |
| Number of subjects with newly diagnosed diabetes. | Number of subjects with newly diagnosed diabetes. | 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.) | Screening, Visit 4(Day 90) |
| Incidence of rhabdomyolysis | Incidence of rhabdomyolysis | 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) | Baseline to Visit 4(up to 90 days) |
| Anyang-si |
| Gyeonggi-do |
| South Korea |
| Myongji Hospital | Goyang-si | Gyeonggi-do | South Korea |
| 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 |
| Seoul St Mary's Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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