A Multicenter Study to Evaluate the Effect of High Dose Rosuvastatin Versus Rosuvastatin and Ezetimibe in Stroke
A Multicenter Prospective Randomized-controlled Interventional Study to Evaluate the Effect of High Dose Rosuvastatin Versus High Dose Rosuvastatin and Ezetimibe in Acute Ischemic Stroke Patients
1 other identifier
interventional
330
1 country
3
Brief Summary
High-intensity statins are recommended for secondary prevention of stroke in patients with atherosclerotic ischemic stroke. According to the guidelines of the American Heart Association and the American Stroke Society, high-intensity or high-dose statins are recommended for high-risk groups of atherosclerotic cardiovascular disease (ASCVD). Statin therapy is recommended even if it is less than 100 mg/dL. The 2016 ESC/EAS and 2017 AACE guidelines include ischemic stroke and transient cerebral ischemic attacks caused by atherosclerosis in ASCVD, classifying them as ultra-high-risk groups, and recommending LDL cholesterol of less than 70 mg/dL as a treatment goal. The recently published guidelines for dyslipidemia in Korea also recommend that the target level of LDL cholesterol in patients with atherosclerotic ischemic stroke and transient ischemic attack be reduced to less than 70 mg/dL or 50% or more from the baseline. According to a previous study on the efficacy and safety of high-intensity rosuvastatin in patients with ischemic stroke, it is not clear whether the use of rosuvastatin 20 mg prevents recurrence of cerebral infarction in the acute stage, but it is safe and effective for hemorrhagic conversion of cerebral infarction. In addition, the results were shown when rosuvastatin and ezetimibe were combined in patients with high cardiovascular risk, LDL cholesterol and total cholesterol decreased more in the combined group than in the single agent group. In a study comparing the group whose LDL cholesterol target was reduced to 70 mg/dL or less after stroke and the group maintained at 90-110 mg/dL, the group whose LDL cholesterol was controlled to 70 mg/dL or less It was confirmed that the incidence of cardiovascular disease was reduced. Existing studies aimed at general high-risk groups, not specific disease groups, and as in this study, studies were not conducted on a single disease group called acute stroke. In addition, there are only limited studies on the effectiveness and safety of diseases that occur mainly in the elderly, such as acute stroke. Therefore, there are currently no studies on the clinical efficacy and safety of high-intensity rosuvastatin and ezetimibe combination therapy for patients with acute cerebral infarction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2022
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 1, 2023
May 1, 2023
1.3 years
April 10, 2023
May 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute value of LDL-C (low-density lipoprotein cholesterol) reduction
low-density lipoprotein cholesterol reduction at 90 days after enrollment
90 days after enrollment
Other Outcomes (9)
Percentage of reaching target LDL-C (low-density lipoprotein cholesterol) levels
90 days after enrollment
Changes in total cholesterol, HDL-C (high-density lipoprotein cholesterol), and TG (Triglyceride) levels at 3 months compared to randomization
90 days after enrollment
Clinical event occurence- major cardiovascular adverse event (MACE)
90 days after enrollment
- +6 more other outcomes
Study Arms (2)
Combination therapy
EXPERIMENTALcombination of high-dose rosuvastatin and ezetimibe
Single therapy
ACTIVE COMPARATORhigh-dose rosuvastatin single administration group
Interventions
combination of rosuvastatin 20mg and ezetimibe 10mg
Eligibility Criteria
You may qualify if:
- Those with primary hypercholesterolemia among those whose lesions were confirmed by brain CT or MRI within 48 hours of the onset of ischemic stroke
- Adults 19 years of age or older
- Patients who agreed to participate in this study
You may not qualify if:
- Patients scheduled for carotid endarterectomy or stenting, cerebral artery stenting, coronary angioplasty and stenting, or coronary artery bypass surgery within 3 months
- Patients with malignant tumors that have not been cured
- Patients who have participated in other drug clinical trials within the last 30 days
- Patients expected to experience side effects when taking rosuvastatin and ezetimibe
- Patients who did not consent to participate in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Koera University Guro Hospital
Seoul, 08308, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 10, 2023
First Posted
June 1, 2023
Study Start
September 1, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
June 1, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share