evaluation of effect of alirocumab on coronary atheroma volume in japanese patients hospitalized for acute coronary syndrome with hypercholesterolemia

Conditions: Hypercholesterolemia; Acute Coronary Syndrome

Summary: 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.

Eligibility criteria:
inclusion criteria : * participants hospitalized for acs (acute st-segment elevation myocardial infarction \[stemi\], acute non-st-segment elevation myocardial infarction \[nstemi\], and unstable angina. * ldl-c \>=100 mg/dl at acs diagnosis. * participants who has stenosis with at least \>50% stenosis angiographically within 1 week after the acs onset, and has analyzable coronary intravascular ultrasound image. * participants aged \>=20 years old at acs diagnosis. * negative hepatitis b surface antigen, negative hepatitis b core antibody, and negative hepatitis c antibody. or, negative hepatitis b surface antigen, positive hepatitis b core antibody, negative hepatitis b deoxyribonucleic acid, and negative hepatitis c antibody. * written informed consent. exclusion criteria: * participants who had previously treated with at least one dose of any anti-proprotein convertase subtilisin/kexin type 9 monoclonal antibody. * uncontrolled hypertension (multiple reading with systolic blood pressure \>180 mmhg or diastolic blood pressure \>110 mmhg) between acs diagnosis and randomization visit. * known history of hemorrhagic stroke. * currently under treatment for cancer. * participants on ldl apheresis. * any clinically significant abnormality identified that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases, participants with short life expectancy. * considered by the investigator or any sub-investigator as inappropriate for this study for any reason, including: * unable to meet specific protocol requirements, such as scheduled visits; * investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol, etc; * presence of any other conditions (eg, geographic, social, etc.) actual or anticipated, that the investigator feels would restrict or limit the participant's participation for the duration of the study. * laboratory findings measured within 4 weeks after the acs diagnosis (positive serum or urine pregnancy test in females of childbearing potential). the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.