ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Phase 1
- Conditions
- Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Acute coronary syndrome-MedDRA version: 17.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders
- Registration Number
- EUCTR2011-005698-21-GR
- Lead Sponsor
- sanofi-aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18000
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 15500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2500
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method