A Multicenter Study to Evaluate the Effect of High Dose Rosuvastatin Versus Rosuvastatin and Ezetimibe in Stroke
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
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.