Brief Summary
Primary Objective:
To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia.
Secondary Objectives:
* To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality).
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the effect of alirocumab on lipid parameters.
To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia.
Secondary Objectives:
* To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality).
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the effect of alirocumab on lipid parameters.
Brief Title
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Detailed Description
18924 number of participants aged \>= 40 years old were randomized in the study.
Completion Date
Completion Date Type
Actual
Conditions
Atherosclerotic Cardiovascular Disease
Eligibility Criteria
Inclusion criteria :
Recently (\< 52 weeks) hospitalized for ACS.
Exclusion criteria:
* Age \< 40 years.
* ACS event occurring more than 52 weeks prior to randomization visit.
* LDL-C likely to be \<70 mg/dL (\<1.81 mmo/L), and apolipoprotein B (ApoB) \<80 mg/dL (\<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) \<100 mg/dL (\<2.59 mmol/L) with evidence-based medical and dietary management of dyslipidemia.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Recently (\< 52 weeks) hospitalized for ACS.
Exclusion criteria:
* Age \< 40 years.
* ACS event occurring more than 52 weeks prior to randomization visit.
* LDL-C likely to be \<70 mg/dL (\<1.81 mmo/L), and apolipoprotein B (ApoB) \<80 mg/dL (\<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) \<100 mg/dL (\<2.59 mmol/L) with evidence-based medical and dietary management of dyslipidemia.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Inclusion Criteria
Inclusion criteria :
Recently (\< 52 weeks) hospitalized for ACS.
Recently (\< 52 weeks) hospitalized for ACS.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
40 Years
NCT Id
NCT01663402
Org Class
Industry
Org Full Name
Sanofi
Org Study Id
EFC11570
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
Primary Outcomes
Outcome Description
All MACE positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the analysis of the composite cardiovascular (CV) outcome measure comprised of Coronary Heart Disease (CHD) death, non-fatal Myocardial Infarction (MI), fatal and non-fatal ischemic stroke (IS), or unstable angina (UA) requiring hospitalization. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of MACE over time. Percentage of observed participants with outcome measure events during the study were reported.
Outcome Measure
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Time Frame
From randomization up to 64 months
Secondary Ids
Secondary Id
2011-005698-21
Secondary Id
U1111-1127-4323
Secondary Outcomes
Outcome Description
All CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death, non-fatal non-fatal MI, UA requiring hospitalization, or ischemia-driven coronary revascularization procedure. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CHD event over time. Percentage of observed participants with outcome measure events during the study were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to First Occurrence of Any Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
All Major CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death and non-fatal MI. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any major CHD event over time. Percentage of observed participants with outcome measure events during the study were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to First Occurrence of Any Major Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
All CV events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CV endpoint comprised of any non-fatal CHD event, any CV death and non-fatal IS. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CV event over time. Percentage of observed participants with outcome measure events during the study were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to First Occurrence of Any Cardiovascular Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
All-cause mortality, non-fatal MI and non-fatal IS positively adjudicated by CEC in a blinded fashion, were used in the analysis of this endpoint. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of all-cause mortality, non-fatal MI and non-fatal IS over time. Percentage of observed participants with outcome measure events during the study were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the CHD death over time. Percentage of observed participants with CHD death (positively adjudicated by CEC in a blinded fashion) were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to Coronary Heart Disease Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the CV death over time. Percentage of observed participants with CV death (positively adjudicated by CEC in a blinded fashion) were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to Cardiovascular Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the all-cause death over time. Percentage of observed participants with all-cause death (positively adjudicated by CEC in a blinded fashion) were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to All-Cause Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any non-fatal MI over time. Percentage of observed participants with any non-fatal MI (positively adjudicated by CEC in a blinded fashion) were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to First Occurrence of Any Non-Fatal Myocardial Infarction; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of fatal or any non-fatal IS over time. Percentage of observed participants with fatal or any non-fatal IS (positively adjudicated by CEC in a blinded fashion) were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any UA requiring hospitalization over time. Percentage of observed participants with any UA requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to First Occurrence of Any Unstable Angina Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any ischemia-driven coronary revascularization procedure over time. Percentage of observed participants with any ischemia-driven coronary revascularization procedure (positively adjudicated by CEC in a blinded fashion) were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure; Percentage of Observed Participants With Outcome Measure Events During the Study
Outcome Description
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CHF requiring hospitalization over time. Percentage of observed participants with any CHF requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported.
Outcome Time Frame
From randomization up to 64 months
Outcome Measure
Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
Anna Bortnick
Investigator Email
abortnic@montefiore.org
Investigator Phone
718 904 3457
Categories Mesh Debug
Heart/Cardiovascular --- ARTERIOSCLEROSIS
Heart/Cardiovascular --- ARTERIAL OCCLUSIVE DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
ATHEROSCLEROSIS
ARTERIOSCLEROSIS
ARTERIAL OCCLUSIVE DISEASES
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
ALIROCUMAB
COUNTERFEIT DRUGS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS