Atherosclerotic Cardiovascular Disease Without Prior Ischemic EventsOPTIMUS-EPICNCT07734753
Impact of Alirocumab on Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events
An observational study of Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events, run by Sanofi at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events
- What is being tested?
- Alirocumab and Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)
- How many people
- 4,006 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jul 2025to 15 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The eligible population includes adults aged ≥18 years with documented ASCVD and no history of myocardial infarction, ischemic stroke, or hospitalization for unstable angina.
Who may be able to join
- Adults aged ≥18 years with documented ASCVD between January 1, 2016, and September 30, 2024.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alirocumab and Cardiovascular Outcomes in Patients Without a Previous Myocardial Infarction or Stroke
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.
Read the 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.
- Being tested
- Alirocumab, Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlirocumabDrug
The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.
Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)Drug
The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Alirocumab | Not described Receives: Drug: Alirocumab | |
| Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents) | Not described Receives: Drug: Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality
Measured: From index up to 5 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Jul 2025
- Primary completion15 May 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular Disease Without Prior Ischemic EventsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 4,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734753
- Sponsor's protocol ID
- SEC27141
- Acronym
- OPTIMUS-EPIC
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alirocumab and Cardiovascular Outcomes in Patients Without a Previous Myocardial Infarction or Stroke
- ClinicalTrials.gov ID
- NCT07734753
- Acronym / sponsor ID
- OPTIMUS-EPIC / SEC27141
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,006 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alirocumab | – | Drug: Alirocumab |
| Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents) | – | Drug: Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible population includes adults aged ≥18 years with documented ASCVD and no history of myocardial infarction, ischemic stroke, or hospitalization for unstable angina.
Key inclusion criteria (4 listed)
- Adults aged ≥18 years with documented ASCVD between January 1, 2016, and September 30, 2024.
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlirocumabThe study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice. | Drug | Alirocumab |
| Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents)The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice. | Drug | Comparator: No PCSK9i Therapy (monoclonal antibodies or small interfering RNA agents) |
Primary outcome
Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality
Time frame: From index up to 5 years follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events, run by Sanofi at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality (time frame: From index up to 5 years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.