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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Atherosclerotic Cardiovascular Disease

Treatments: Drug: Alirocumab; Drug: Placebo; Drug: LMT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01663402

U1111-1127-4323 (Other Identifier)

2011-005698-21 (EudraCT Number)

EFC11570

Details and patient eligibility

About

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.

Full description

18924 number of participants aged >= 40 years old were randomized in the study.

Enrollment: 18,924 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18,924 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months.

Treatment:

Drug: Placebo

Drug: LMT

Alirocumab 75 mg Q2W/Up to 150 mg Q2W

Experimental group

Description:

Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when Low-Density Lipoprotein Cholesterol (LDL-C) levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L).

Treatment:

Drug: Alirocumab

Drug: LMT