Alirocumab and Cardiovascular Outcomes in Patients Without a Previous Myocardial Infarction or Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 4,006
- Locations
- 1
- Primary Endpoint
- Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality
Study Overview
Brief Summary
To estimate ischemic event rates in individuals with established atherosclerotic cardiovascular disease (ASCVD) and no prior acute ischemic events, comparing alirocumab with no Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor therapy, using a target trial emulation of routine clinical practice data.
Detailed Description
This study estimates the effect of alirocumab versus no PCSK9 inhibitor on major cardiovascular events in individuals with established ASCVD and no prior ischemic events, using a target trial emulation of routine clinical practice data from the Netherlands.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged ≥18 years with documented ASCVD between January 1, 2016, and September 30,
- •No history of myocardial infarction, ischemic stroke, or hospitalization for unstable angina on or before the index date.
- •Minimum of 12 months of continuous healthcare data availability prior to the index date
- •No exposure to any PCSK9 inhibitor in the 2 years preceding the index date.
Exclusion Criteria
- •- Participants with a history of prior ischemic events.
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Arms & Interventions
Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)
Intervention: Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents) (Drug)
Alirocumab
Intervention: Alirocumab (Drug)
Outcomes
Primary Outcomes
Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality
Time Frame: From index up to 5 years follow up
Secondary Outcomes
No secondary outcomes reported