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Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia (ODYSSEY J-IVUS)

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ClinicalTrials.gov Identifier: NCT02984982
Recruitment Status : Completed
First Posted : December 7, 2016
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypercholesterolemia
Acute Coronary Syndrome
Interventions Drug: Alirocumab SAR236553
Drug: Atorvastatin
Drug: Rosuvastatin
Drug: Fenofibrate
Drug: Bezafibrate
Drug: Ezetimibe
Drug: Antiplatelets
Drug: Anticoagulants
Enrollment 206
Recruitment Details 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.
Pre-assignment Details Randomization was stratified by ‘on statin therapy’ or ‘not on statin therapy’ at the time of acute coronary syndrome (ACS) onset.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin greater than or equal to [>=] 10 milligram per day [mg/day] or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-proprotein convertase subtilisin kexin type 9 (non-PCSK9) inhibitor lipid modifying therapies (LMTs) could be added by the investigators, if low-density lipoprotein cholesterol (LDL-C) target level less than (<) 100 milligrams per deciliter (mg/dL) could not be achieved. Alirocumab (Praluent®) 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Period Title: Overall Study
Started 102 104
Treated 102 103
Completed 94 94
Not Completed 8 10
Reason Not Completed
Adverse Event             2             5
Poor Compliance to Protocol             4             4
Withdrawal by Subject             2             0
Randomized but not treated             0             1
Arm/Group Title Standard of Care Alirocumab Total
Hide Arm/Group Description During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved. Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL. Total of all reporting groups
Overall Number of Baseline Participants 102 104 206
Hide Baseline Analysis Population Description
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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 104 participants 206 participants
60.0  (11.9) 61.7  (10.9) 60.9  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 104 participants 206 participants
Female
19
  18.6%
21
  20.2%
40
  19.4%
Male
83
  81.4%
83
  79.8%
166
  80.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 104 participants 206 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
102
 100.0%
104
 100.0%
206
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Calculated LDL-C in mg/dL   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 98 participants 103 participants 201 participants
95.2  (22.6) 98.5  (22.9) 96.9  (22.8)
[1]
Measure Description: Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - high density lipoprotein [HDL] cholesterol - [Triglycerides/5]).
[2]
Measure Analysis Population Description: “Number analyzed” = Number of participants evaluable for the specified baseline measure.
1.Primary Outcome
Title Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population: all participants who were allocated to a randomized treatment, recorded in the registration center database, had at least one dose or part of dose of study drug and had 2 analyzable normalized TAV values, 1 assessed before randomization, and one assessed after 24 weeks of treatment.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-3.14  (0.97) -4.79  (0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Alirocumab
Comments Analysis was performed using ANCOVA model which included fixed categorical effects of treatment arm and randomization strata, as well as the continuous fixed covariate of baseline normalized TAV.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2279
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.64
Confidence Interval (2-Sided) 95%
-4.32 to 1.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.36
Estimation Comments Standard of Care vs Alirocumab
2.Secondary Outcome
Title Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Least Squares Mean (Standard Error)
Unit of Measure: percent atheroma volume
-1.28  (0.39) -1.42  (0.38)
3.Secondary Outcome
Title Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Least Squares Mean (Standard Error)
Unit of Measure: cubic millimeter (mm^3)
-4.73  (1.02) -5.77  (1.00)
4.Secondary Outcome
Title Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Mean (Standard Error)
Unit of Measure: mm^3
-8.23  (1.85) -10.01  (1.81)
5.Secondary Outcome
Title Percent Change From Baseline in External Elastic Membrane Volume at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 milligram per day [mg/day] or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor lipid modifying therapies (LMTs) could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Mean (Standard Error)
Unit of Measure: percent change
-0.86  (0.93) -3.18  (0.91)
6.Secondary Outcome
Title Absolute Change From Baseline in Lumen Volume at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Mean (Standard Error)
Unit of Measure: mm^3
-1.25  (1.38) -0.93  (1.35)
7.Secondary Outcome
Title Percent Change From Baseline in Lumen Volume at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Mean (Standard Error)
Unit of Measure: percent change
1.20  (1.26) -0.86  (1.23)
8.Secondary Outcome
Title Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline calculated LDL-C values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 85 93
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 12 -9.6  (1.7) -62.4  (1.6)
Week 36 -15.5  (1.8) -63.2  (1.8)
9.Secondary Outcome
Title Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population with one baseline and at least one post-baseline calculated LDL-C values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 85 93
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Week 12 -7.57  (1.91) -64.53  (1.83)
Week 36 -13.40  (1.99) -63.94  (1.91)
10.Secondary Outcome
Title Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and one post-baseline Apo B values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 88 92
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-16.8  (1.4) -51.0  (1.3)
11.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and one post-baseline Apo B values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 88 92
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-16.61  (1.56) -55.13  (1.53)
12.Secondary Outcome
Title Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-20.3  (2.0) -69.2  (2.0)
13.Secondary Outcome
Title Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-14.06  (1.71) -54.50  (1.67)
14.Secondary Outcome
Title Absolute Change From Baseline in Total Cholesterol (TC) at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline TC values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-15.2  (2.3) -61.7  (2.2)
15.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline TC values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-7.59  (1.35) -35.43  (1.32)
16.Secondary Outcome
Title Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and post-baseline Lp(a) values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 88 92
Mean (Standard Error)
Unit of Measure: mg/dL
-10.3  (0.5) -15.5  (0.5)
17.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and one post-baseline Lp(a) values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 88 92
Mean (Standard Error)
Unit of Measure: percent change
-17.23  (2.60) -55.76  (2.54)
18.Secondary Outcome
Title Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline HDL-C values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
4.7  (0.9) 8.1  (0.9)
19.Secondary Outcome
Title Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline HDL-C values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Least Squares Mean (Standard Error)
Unit of Measure: percent change
12.19  (2.30) 21.04  (2.25)
20.Secondary Outcome
Title Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline fasting TGs values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Mean (Standard Error)
Unit of Measure: mg/dL
-26.2  (4.7) -35.3  (4.5)
21.Secondary Outcome
Title Percent Change From Baseline in Fasting Triglycerides at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline fasting TGs values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 89 93
Mean (Standard Error)
Unit of Measure: percent change
-8.85  (3.62) -18.37  (3.51)
22.Secondary Outcome
Title Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and one post-baseline Apo A-1 values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 88 92
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
3.8  (1.9) 12.0  (1.9)
23.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein A-1 at Week 36
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and one post-baseline Apo A-1 values.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 88 92
Least Squares Mean (Standard Error)
Unit of Measure: percent change
4.61  (1.62) 11.75  (1.58)
24.Secondary Outcome
Title Number of Participants With Cardiovascular (CV) Adverse Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who actually received at least 1 dose or part of a dose of the study drug, and analyzed according to the treatment actually received.
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description:
During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved.
Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
Overall Number of Participants Analyzed 102 103
Measure Type: Count of Participants
Unit of Measure: Participants
Cardiovascular death
0
   0.0%
0
   0.0%
Myocardial infarction
3
   2.9%
2
   1.9%
Ischemic stroke
0
   0.0%
2
   1.9%
Unstable angina requiring hospitalization
0
   0.0%
0
   0.0%
Congestive heart failure requiring hospitalization
0
   0.0%
0
   0.0%
Ischemia led coronary revascularization procedure
2
   2.0%
4
   3.9%
Time Frame 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
Adverse Event Reporting Description Reported AEs and deaths are treatment-emergent adverse events that developed/worsened during the treatment-emergent period (time from first dose of investigational medicinal product (IMP) up to last dose of IMP +21 days, or end of study, whichever comes first). Analysis was performed on safety population.
 
Arm/Group Title Standard of Care Alirocumab
Hide Arm/Group Description During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level <100 mg/dL could not be achieved. Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day). Statin (atorvastatin >=10 mg/day or rosuvastatin >=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was >=100 mg/dL.
All-Cause Mortality
Standard of Care Alirocumab
Affected / at Risk (%) Affected / at Risk (%)
Total   1/102 (0.98%)   0/103 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Standard of Care Alirocumab
Affected / at Risk (%) Affected / at Risk (%)
Total   17/102 (16.67%)   19/103 (18.45%) 
Cardiac disorders     
Acute coronary syndrome  1  1/102 (0.98%)  0/103 (0.00%) 
Acute myocardial infarction  1  2/102 (1.96%)  2/103 (1.94%) 
Angina unstable  1  1/102 (0.98%)  0/103 (0.00%) 
Cardiac failure  1  1/102 (0.98%)  0/103 (0.00%) 
Coronary artery dissection  1  0/102 (0.00%)  1/103 (0.97%) 
Coronary artery stenosis  1  0/102 (0.00%)  3/103 (2.91%) 
Myocardial infarction  1  2/102 (1.96%)  1/103 (0.97%) 
Myocardial ischaemia  1  3/102 (2.94%)  1/103 (0.97%) 
Prinzmetal angina  1  1/102 (0.98%)  0/103 (0.00%) 
Ventricular tachycardia  1  1/102 (0.98%)  0/103 (0.00%) 
Gastrointestinal disorders     
Haemorrhoids  1  1/102 (0.98%)  0/103 (0.00%) 
Incarcerated inguinal hernia  1  0/102 (0.00%)  1/103 (0.97%) 
General disorders     
Vascular stent stenosis  1  0/102 (0.00%)  1/103 (0.97%) 
Hepatobiliary disorders     
Drug-induced liver injury  1  0/102 (0.00%)  1/103 (0.97%) 
Hepatic function abnormal  1  0/102 (0.00%)  1/103 (0.97%) 
Liver disorder  1  0/102 (0.00%)  1/103 (0.97%) 
Infections and infestations     
Anal abscess  1  0/102 (0.00%)  1/103 (0.97%) 
Gastroenteritis  1  0/102 (0.00%)  1/103 (0.97%) 
Pneumonia  1  2/102 (1.96%)  1/103 (0.97%) 
Sepsis  1  1/102 (0.98%)  0/103 (0.00%) 
Injury, poisoning and procedural complications     
Coronary artery reocclusion  1  0/102 (0.00%)  1/103 (0.97%) 
Vascular pseudoaneurysm  1  1/102 (0.98%)  0/103 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung adenocarcinoma stage I  1  0/102 (0.00%)  1/103 (0.97%) 
Rectal cancer  1  1/102 (0.98%)  0/103 (0.00%) 
Nervous system disorders     
Cerebral infarction  1  0/102 (0.00%)  2/103 (1.94%) 
Transient ischaemic attack  1  1/102 (0.98%)  1/103 (0.97%) 
Renal and urinary disorders     
Nephropathy toxic  1  0/102 (0.00%)  1/103 (0.97%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  0/102 (0.00%)  1/103 (0.97%) 
Pneumothorax  1  0/102 (0.00%)  1/103 (0.97%) 
Vascular disorders     
Peripheral arterial occlusive disease  1  0/102 (0.00%)  1/103 (0.97%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard of Care Alirocumab
Affected / at Risk (%) Affected / at Risk (%)
Total   15/102 (14.71%)   33/103 (32.04%) 
General disorders     
Injection site reaction  1  0/102 (0.00%)  7/103 (6.80%) 
Infections and infestations     
Nasopharyngitis  1  15/102 (14.71%)  27/103 (26.21%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/102 (0.00%)  6/103 (5.83%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02984982     History of Changes
Other Study ID Numbers: ALIROL08069
U1111-1184-8764 ( Other Identifier: UTN )
First Submitted: December 5, 2016
First Posted: December 7, 2016
Results First Submitted: July 26, 2019
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019