Stroke, Ischemic Clinical Trial
Official title:
Moderate-intensity Rosuvastatin Plus Ezetimibe Versus High-intensity Rosuvastatin for Target LDL-C Goal Achievement in Patients With Recent Ischemic Stroke: a Randomized Clinical Trial
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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