Atherosclerotic Cardiovascular Disease Without Prior Ischemic EventsOPTIMUS-IMPACTNCT07615179
Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)
An observational study of Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events, run by Sanofi at 1 site in United States.
Trial summary
The objective of this study is to evaluate ischemic event rates among individuals with established atherosclerotic cardiovascular disease without prior acute ischemic events, comparing those treated with alirocumab versus those receiving no proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) therapy. 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 (either mAb or siRNA)
- How many people
- 4,545 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2025to 30 May 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: Participants who initiated treatment with Alirocumab from January 01, 2016 till December 31, 2022.
Who may be able to join
- Adult participants (aged ≥18 years at index) with ASCVD without evidence of prior ischemic events (myocardial infarction, unstable angina, or ischemic stroke) will be included.
- Participants initiating Alirocumab will be initially selected, with index (time zero) set as initiation of therapy. This index will be a point where the participants meet all the inclusion criteria in a hypothetical trial enrolling this population who would qualify for therapy.
Who cannot join
- Participants with evidence of ischemic events either concurrent with or prior to the earliest record of ASCVD will be excluded.
- 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: Impact of Alirocumab on Cardiovascular Events in Individuals With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events
The objective of this study is to evaluate ischemic event rates among individuals with established atherosclerotic cardiovascular disease without prior acute ischemic events, comparing those treated with alirocumab versus those receiving no proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) therapy. The study will leverage observational data reflective of routine clinical practice and will apply contemporary approaches in target trial emulation and causal inference to estimate treatment effects.
Read the detailed description
The study aims to estimate the reduction in major cardiovascular events (MACE) with intensive lipid lowering therapy (LLT) via Alirocumab in a population with ASCVD but without a history of ischemic events. The current study will closely mirror the adopted methodological approach for the prior investigation of the impact of PCSK9i mAb class on MACE in this population.
- Being tested
- Alirocumab, Comparator: No PCSK9i Therapy (either mAb or siRNA)
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 (either mAb or siRNA)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 (either mAb or siRNA) | Not described Receives: Drug: Comparator: No PCSK9i Therapy (either mAb or siRNA) |
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 May 2026
- Study start17 Feb 2025
- Primary completion30 Sep 2025
- Study completion30 May 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
- 4,545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615179
- Sponsor's protocol ID
- CEF0220
- Acronym
- OPTIMUS-IMPACT
- Status last verified
- Sep 2026
- First submitted
- 22 May 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Alirocumab on Cardiovascular Events in Individuals With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events
- ClinicalTrials.gov ID
- NCT07615179
- Acronym / sponsor ID
- OPTIMUS-IMPACT / CEF0220
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,545 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 29 May 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.
The objective of this study is to evaluate ischemic event rates among individuals with established atherosclerotic cardiovascular disease without prior acute ischemic events, comparing those treated with alirocumab versus those receiving no proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) therapy. The study will leverage observational data reflective of routine clinical practice and will apply contemporary approaches in target trial emulation and causal inference to estimate treatment effects.
Detailed description
The study aims to estimate the reduction in major cardiovascular events (MACE) with intensive lipid lowering therapy (LLT) via Alirocumab in a population with ASCVD but without a history of ischemic events. The current study will closely mirror the adopted methodological approach for the prior investigation of the impact of PCSK9i mAb class on MACE in this population.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alirocumab | – | Drug: Alirocumab |
| Comparator: No PCSK9i Therapy (either mAb or siRNA) | – | Drug: Comparator: No PCSK9i Therapy (either mAb or siRNA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who initiated treatment with Alirocumab from January 01, 2016 till December 31, 2022.
Key inclusion criteria (2 listed)
- Adult participants (aged ≥18 years at index) with ASCVD without evidence of prior ischemic events (myocardial infarction, unstable angina, or ischemic stroke) will be included.
- Participants initiating Alirocumab will be initially selected, with index (time zero) set as initiation of therapy. This index will be a point where the participants meet all the inclusion criteria in a hypothetical trial enrolling this population who would qualify for therapy.
Key exclusion criteria (2 listed)
- Participants with evidence of ischemic events either concurrent with or prior to the earliest record of ASCVD will be excluded.
- 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 (either mAb or siRNA)The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice. | Drug | Comparator: No PCSK9i Therapy (either mAb or siRNA) |
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 8 Sep 2026.
- Individual participant dataSharing planned: No
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A Retrospective Cohort Study Evaluating Major Adverse Cardiovascular Events and Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events (OPTIMUS RISK - Spain)
Atherosclerotic Cardiovascular Disease
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 United States.
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 2 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 8 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 United States. 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 8 Sep 2026.