Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36

LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effects, and the baseline PAV as continuous fixed covariate.

Time frame: Baseline, Week 36

Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36

LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.

Time frame: Baseline, Week 36

Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36

Adjusted mean and SE at Week 36 were obtained from robust regression model with treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]), as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.

Time frame: Baseline, Week 36

Percent Change From Baseline in External Elastic Membrane Volume at Week 36

Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.

Time frame: Baseline, Week 36

Absolute Change From Baseline in Lumen Volume at Week 36

Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effects, and the baseline lumen volume value as continuous fixed covariate.

Time frame: Baseline, Week 36

Percent Change From Baseline in Lumen Volume at Week 36

Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effect, and the baseline lumen volume value as continuous fixed covariate.

Time frame: Baseline, Week 36

Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36

Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset \[Yes / No\]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.

Time frame: Baseline, Week 12, Week 36

Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36

Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset \[Yes / No\]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.

Time frame: Baseline, Week 12, Week 36

Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36

Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.

Time frame: Baseline, Week 36

Percent Change From Baseline in Apolipoprotein B at Week 36

Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.

Time frame: Baseline, Week 36

Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36

Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset \[Yes / No\]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.

Time frame: Baseline, Week 36

Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36

Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset \[Yes / No\]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.

Time frame: Baseline, Week 36

Absolute Change From Baseline in Total Cholesterol (TC) at Week 36

LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset \[Yes / No\]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated TC value and baseline calculated TC value-by-time point interaction as continuous fixed covariates.

Time frame: Baseline, Week 36

Percent Change From Baseline in Total Cholesterol at Week 36

Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset \[Yes / No\]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline TC value and baseline TC value-by-time point interaction as continuous fixed covariates.

Time frame: Baseline, Week 36

Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36

Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.

Time frame: Baseline, Week 36

Percent Change From Baseline in Lipoprotein (a) at Week 36

Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.

Time frame: Baseline, Week 36

Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36

Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset \[Yes / No\]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.

Time frame: Baseline, Week 36

Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36

Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset \[Yes / No\]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.

Time frame: Baseline, Week 36

Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36

Adjusted mean and SE were obtained from multiple imputation approach followed by robust regression model including fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) and the continuous fixed covariate of baseline fasting TGs value.

Time frame: Baseline, Week 36

Percent Change From Baseline in Fasting Triglycerides at Week 36

Adjusted mean and SE were obtained by multiple imputation approach followed by robust regression model included fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) and the continuous fixed covariate of baseline fasting TGs value.

Time frame: Baseline, Week 36

Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36

Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.

Time frame: Baseline, Week 36

Percent Change From Baseline in Apolipoprotein A-1 at Week 36

Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset \[Yes / No\]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.

Time frame: Baseline, Week 36

Number of Participants With Cardiovascular (CV) Adverse Events

The suspected or confirmed CV events that occurred from randomization until end of the study visit were collected and reported. The various CV events included CV death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalization , congestive heart failure requiring hospitalization, congestive heart failure requiring hospitalization, ischemia-driven coronary revascularization procedure.

Time frame: Up to 36 weeks