Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With SAR236553 (REGN727) (ODYSSEY Outcomes)

• 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 SAR236553 (REGN727) 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 16 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.

Secondary Objectives:

To evaluate the effect of SAR236553 (REGN727) 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 SAR236553 (REGN727). To evaluate the effect of SAR236553 (REGN727) on lipid parameters.

The maximum study duration will be 70 months, including up to a 4-month run-in period, 64 months randomized treatment period, and 2-month follow-up period.

• Drug: SAR236553 (REGN727)

  SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

  Pharmaceutical form:solution for injection Route of administration: subcutaneous

• Other: placebo
  Pharmaceutical form:solution for injection Route of administration: subcutaneous

• Experimental: SAR236553 (REGN727)
  Injection through subcutaneous (SC) administration - Type: Experimental
  Intervention: Drug: SAR236553 (REGN727)
• Placebo
  Injection through subcutaneous (SC) administration - Type: Placebo Comparator
  Intervention: Other: placebo

Inclusion criteria:

- Recently hospitalized for ACS.

Exclusion criteria:

• Age < 40 years.
• ACS event occurring more than 16 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.