A Phase 4 interventional study of Alirocumab SAR236553 and Atorvastatin in Hypercholesterolemia and Acute Coronary Syndrome, sponsored by Sanofi. Completed at 39 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-09-09.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
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:
The duration of study per participant was 9 months.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 206 is close to the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Considered by the Investigator or any sub-Investigator as inappropriate for this study for any reason, including:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level \<100 milligrams per deciliter (mg/dL).
Drug: Atorvastatin · Drug: Rosuvastatin · Drug: Fenofibrate · Drug: Bezafibrate · Drug: Ezetimibe · Drug: Antiplatelets · Drug: Anticoagulants
Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.
Drug: Alirocumab SAR236553 · Drug: Atorvastatin · Drug: Rosuvastatin · Drug: Fenofibrate · Drug: Bezafibrate · Drug: Ezetimibe · Drug: Antiplatelets · Drug: Anticoagulants
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Also known as: Praluent
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet or capsule Route of administration: oral
Pharmaceutical form: tablet or capsule Route of administration: oral
Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36
Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (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 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
The study was conducted at 39 active centers in Japan. Overall 214 participants were screened between 15 November 2016 and 02 November 2017, of whom 8 were screen failure and 206 were randomized to either alirocumab arm or standard of care (SoC) arm.
| Milestone | Standard of Care | Alirocumab |
|---|---|---|
| Started | 102 | 104 |
| Treated | 102 | 103 |
| Completed | 94 | 94 |
| Not completed | 8 | 10 |
| Withdrew: Adverse event | 2 | 5 |
| Withdrew: Poor compliance to protocol | 4 | 4 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Randomized but not treated | 0 | 1 |
Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36 | -3.14 ± 0.97 | -4.79 ± 0.95 |
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.
| percent atheroma volume | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36 | -1.28 ± 0.39 | -1.42 ± 0.38 |
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.
| cubic millimeter (mm^3) | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36 | -4.73 ± 1.02 | -5.77 ± 1.00 |
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.
| mm^3 | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36 | -8.23 ± 1.85 | -10.01 ± 1.81 |
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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Percent Change From Baseline in External Elastic Membrane Volume at Week 36 | -0.86 ± 0.93 | -3.18 ± 0.91 |
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.
| mm^3 | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in Lumen Volume at Week 36 | -1.25 ± 1.38 | -0.93 ± 1.35 |
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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Percent Change From Baseline in Lumen Volume at Week 36 | 1.20 ± 1.26 | -0.86 ± 1.23 |
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.
| mg/dL | Standard of Care | Alirocumab |
|---|---|---|
| Week 12 | -9.6 ± 1.7 | -62.4 ± 1.6 |
| Week 36 | -15.5 ± 1.8 | -63.2 ± 1.8 |
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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Week 12 | -7.57 ± 1.91 | -64.53 ± 1.83 |
| Week 36 | -13.40 ± 1.99 | -63.94 ± 1.91 |
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.
| mg/dL | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36 | -16.8 ± 1.4 | -51.0 ± 1.3 |
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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Percent Change From Baseline in Apolipoprotein B at Week 36 | -16.61 ± 1.56 | -55.13 ± 1.53 |
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.
| mg/dL | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36 | -20.3 ± 2.0 | -69.2 ± 2.0 |
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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36 | -14.06 ± 1.71 | -54.50 ± 1.67 |
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.
| mg/dL | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in Total Cholesterol (TC) at Week 36 | -15.2 ± 2.3 | -61.7 ± 2.2 |
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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Percent Change From Baseline in Total Cholesterol at Week 36 | -7.59 ± 1.35 | -35.43 ± 1.32 |
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.
| mg/dL | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36 | -10.3 ± 0.5 | -15.5 ± 0.5 |
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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Percent Change From Baseline in Lipoprotein (a) at Week 36 | -17.23 ± 2.60 | -55.76 ± 2.54 |
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.
| mg/dL | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36 | 4.7 ± 0.9 | 8.1 ± 0.9 |
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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36 | 12.19 ± 2.30 | 21.04 ± 2.25 |
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.
| mg/dL | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36 | -26.2 ± 4.7 | -35.3 ± 4.5 |
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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Percent Change From Baseline in Fasting Triglycerides at Week 36 | -8.85 ± 3.62 | -18.37 ± 3.51 |
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.
| mg/dL | Standard of Care | Alirocumab |
|---|---|---|
| Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36 | 3.8 ± 1.9 | 12.0 ± 1.9 |
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.
| percent change | Standard of Care | Alirocumab |
|---|---|---|
| Percent Change From Baseline in Apolipoprotein A-1 at Week 36 | 4.61 ± 1.62 | 11.75 ± 1.58 |
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.
| Participants | Standard of Care | Alirocumab |
|---|---|---|
| Cardiovascular death | 0 | 0 |
| Myocardial infarction | 3 | 2 |
| Ischemic stroke | 0 | 2 |
| Unstable angina requiring hospitalization | 0 | 0 |
| Congestive heart failure requiring hospitalization | 0 | 0 |
| Ischemia led coronary revascularization procedure | 2 | 4 |
Collected over All Adverse Events (AEs) were collected from signature of the informed consent form up to 21 days after last dose of study drug, or end of study, whichever comes first (up to 39 weeks) regardless of seriousness or relationship to investigational product. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 1/102 (1%) | 17/102 (16.7%) | 15/102 (14.7%) |
| Alirocumab | 0/103 (0%) | 19/103 (18.4%) | 33/103 (32%) |
| Event | Standard of Care | Alirocumab |
|---|---|---|
| Myocardial ischaemiaCardiac disorders | 3/102 | 1/103 |
| Coronary artery stenosisCardiac disorders | 0/102 | 3/103 |
| PneumoniaInfections and infestations | 2/102 | 1/103 |
| Acute myocardial infarctionCardiac disorders | 2/102 | 2/103 |
| Myocardial infarctionCardiac disorders | 2/102 | 1/103 |
| Cerebral infarctionNervous system disorders | 0/102 | 2/103 |
| SepsisInfections and infestations | 1/102 | 0/103 |
| Rectal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/102 | 0/103 |
| Transient ischaemic attackNervous system disorders | 1/102 | 1/103 |
| Acute coronary syndromeCardiac disorders | 1/102 | 0/103 |
| Event | Standard of Care | Alirocumab |
|---|---|---|
| NasopharyngitisInfections and infestations | 15/102 | 27/103 |
| Injection site reactionGeneral disorders | 0/102 | 7/103 |
| Back painMusculoskeletal and connective tissue disorders | 0/102 | 6/103 |
Randomized population included all participants who were allocated to a randomized treatment and recorded in the registration center database, regardless of whether a study drug was used or not.
| Age, Continuous(years) | Standard of Care | Alirocumab | Total |
|---|---|---|---|
| Mean | 60.0 ± 11.9 | 61.7 ± 10.9 | 60.9 ± 11.4 |
| Sex: Female, Male(Participants) | Standard of Care | Alirocumab | Total |
|---|---|---|---|
| Female | 19 | 21 | 40 |
| Male | 83 | 83 | 166 |
| Race (NIH/OMB)(Participants) | Standard of Care | Alirocumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 102 | 104 | 206 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Calculated LDL-C in mg/dL(mg/dL) | Standard of Care | Alirocumab | Total |
|---|---|---|---|
| Mean | 95.2 ± 22.6 | 98.5 ± 22.9 | 96.9 ± 22.8 |
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