ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

• Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]
• Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]

• Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]
• Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]
• Number of patients with adverse events [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]

Primary Objective:

To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are 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, all cause mortality).
• To evaluate the safety and tolerability of alirocumab.
• To evaluate the effect of alirocumab on lipid parameters.

The maximum study duration will be 64 months, including up to a 4-month run-in period, 60 months randomized treatment period.

Number of patients aged from 18 to 64 years and >= 65 years old are based on the number of randomized patients (18600 patients).

• Drug: alirocumab

  Pharmaceutical form: solution for injection

  Route of administration: subcutaneous

  Other Names:

  • SAR236553
  • REGN727
• Drug: Placebo

  Pharmaceutical form: solution for injection

  Route of administration: subcutaneous

• Experimental: Alirocumab

  Injection through subcutaneous (SC) administration

  Alirocumab is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

  Intervention: Drug: alirocumab
• Placebo Comparator: Placebo
  Injection through subcutaneous (SC) administration
  Intervention: Drug: Placebo

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) with evidence-based medical and dietary management of dyslipidemia.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.