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

Phase 1

• Conditions: Acute coronary syndrome; MedDRA version: 19.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-005698-21-EE
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-20
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18600

Inclusion Criteria

o Recently (<52 weeks) hospitalized for ACS.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2600

Exclusion Criteria

o Age < 40 years.
o ACS event occurring more than 52 weeks prior to randomization visit.
o LDL-C likely to be <70 mg/dL (<1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified