Cardiovascular Diseases Clinical Trial
Official title:
Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin: Study Protocol for a Randomized Controlled Trial
This study is a multicenter, randomized, open-label, parallel, phase IV trial.
The purpose of this study efficacy and safety of combination therapy of moderate-intensity
statin and ezetimibe compared to high-intensity statin.
The study is planned to include 272 patients with a clinical atherosclerotic cardiovascular
disease requiring optimal statin therapy.
After enrollment, subjects are randomized into two groups in a 1:1 manner. The combination
therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10
mg once daily.
The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.
Subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side
effects.
The primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12
weeks.
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