Acute Coronary Syndrome Clinical Trial
Official title:
A Randomized, Open-label, Blinded Intravascular Ultrasound Analysis, Parallel Group, Multicenter Study to Evaluate the Effect of Praluent® (Alirocumab) on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia Not Adequately Controlled With Statin
Primary Objective:
To compare the efficacy of alirocumab (Praluent®) with standard of care (SoC) on coronary
atheroma progression (percent change in normalized total atheroma volume [TAV]) after 9
months of treatment in participants who had acute coronary syndrome (ACS) within 4 weeks
prior to randomization, with hypercholesterolemia treated with statin.
Secondary Objectives:
- To compare the efficacy of alirocumab (Praluent®) with SoC on secondary endpoints
including absolute change in percent atheroma volume and normalized TAV after 9 months
of treatment.
- To evaluate the efficacy of alirocumab (Praluent®) on low-density lipoprotein
cholesterol (LDL-C), apolipoprotein B, triglycerides, non-high-density lipoprotein
cholesterol and lipoprotein (a) after 9 months treatment.
- To evaluate the safety of alirocumab (Praluent®) including the occurrence of
cardiovascular events (coronary heart disease death, non-fatal myocardial infarction,
fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization)
throughout the study.
The duration of study per participant was 9 months. ;
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