Atherosclerotic Cardiovascular DiseaseNCT07906132
A Retrospective Cohort Study Evaluating Major Adverse Cardiovascular Events and Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events (OPTIMUS RISK - Italy)
An observational study of Atherosclerotic Cardiovascular Disease, run by Sanofi at 1 site in Italy.
Trial summary
This study will evaluate cardiovascular outcomes among individuals with clinically established atherosclerotic cardiovascular disease (ASCVD) who have not previously experienced a myocardial infarction (MI) or ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- How many people
- 93,000 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2025to 18 Oct 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 with evidence of ASCVD will be identified using diagnostic and procedural codes during a predefined identification period, January 1,2016, to December 31, 2024.
Who may be able to join
- Adults aged 18 years or older at the index date (date of incident ASCVD diagnosis).
- Continuous data availability for at least 12 months before the index date.
- No evidence of myocardial infarction, ischemic stroke, or hospitalization for unstable angina on the index date or within 14 days following initial ASCVD identification.
Who cannot join
- Prior history of ASCVD before the index date, including myocardial infarction, ischemic stroke, unstable angina, coronary revascularization, carotid artery disease, peripheral artery disease, or other ASCVD diagnoses.
- 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: Major Adverse Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events: Rates, Risk Factors, and Patient Characteristics From Routine Clinical Practice Data Sources
This study will evaluate cardiovascular outcomes among individuals with clinically established atherosclerotic cardiovascular disease (ASCVD) who have not previously experienced a myocardial infarction (MI) or ischemic stroke. The study will evaluate a composite outcome comprising nonfatal MI, nonfatal ischemic stroke, cardiovascular death, and/or all-cause mortality. Additionally, risk factors for experiencing cardiovascular outcomes and lipid lowering therapy use will be evaluated.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants With ASCVD Without Prior Ischemic Events | Participants with ASCVD and no prior history of ischemic events, including myocardial infarction or ischemic stroke, at cohort entry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Composite of nonfatal myocardial infarction, nonfatal ischemic stroke, or all-cause mortality.
Measured: From index up to 5 years follow up
Secondary outcomes (5)
Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or Cardiovascular Mortality
Measured: From index date up to 5 years of follow-up
Occurrence of Nonfatal Myocardial Infarction
Measured: From index date up to 5 years of follow-up
Occurrence of Nonfatal Ischemic Stroke
Measured: From index date up to 5 years of follow-up
All-Cause Mortality
Death due to any cause during follow-up.
Measured: From index date up to 5 years of follow-up
Cardiovascular Mortality
Cardiovascular death during follow-up.
Measured: From index date up to 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start7 Nov 2025
- Primary completion11 Jul 2026
- Study completion18 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906132
- Sponsor's protocol ID
- SEC28055
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Major Adverse Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events: Rates, Risk Factors, and Patient Characteristics From Routine Clinical Practice Data Sources
- ClinicalTrials.gov ID
- NCT07906132
- Acronym / sponsor ID
- SEC28055
- Conditions
- Atherosclerotic Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93,000 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 11 Jul 2026 (actual)
- Study completion
- 18 Oct 2026 (actual)
- First posted
- 30 Oct 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.
This study will evaluate cardiovascular outcomes among individuals with clinically established atherosclerotic cardiovascular disease (ASCVD) who have not previously experienced a myocardial infarction (MI) or ischemic stroke. The study will evaluate a composite outcome comprising nonfatal MI, nonfatal ischemic stroke, cardiovascular death, and/or all-cause mortality. Additionally, risk factors for experiencing cardiovascular outcomes and lipid lowering therapy use will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With ASCVD Without Prior Ischemic Events | – | –Participants with ASCVD and no prior history of ischemic events, including myocardial infarction or ischemic stroke, at cohort entry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with evidence of ASCVD will be identified using diagnostic and procedural codes during a predefined identification period, January 1,2016, to December 31, 2024.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older at the index date (date of incident ASCVD diagnosis).
- Continuous data availability for at least 12 months before the index date.
- No evidence of myocardial infarction, ischemic stroke, or hospitalization for unstable angina on the index date or within 14 days following initial ASCVD identification.
Key exclusion criteria (2 listed)
- Prior history of ASCVD before the index date, including myocardial infarction, ischemic stroke, unstable angina, coronary revascularization, carotid artery disease, peripheral artery disease, or other ASCVD diagnoses.
- 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.
Primary outcome
Major Adverse Cardiovascular Events
Time frame: From index up to 5 years follow up
Composite of nonfatal myocardial infarction, nonfatal ischemic stroke, or all-cause mortality.
5 secondary outcomes
Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or Cardiovascular Mortality
Time frame: From index date up to 5 years of follow-up
Occurrence of Nonfatal Myocardial Infarction
Time frame: From index date up to 5 years of follow-up
Occurrence of Nonfatal Ischemic Stroke
Time frame: From index date up to 5 years of follow-up
All-Cause Mortality
Time frame: From index date up to 5 years of follow-up
Cardiovascular Mortality
Time frame: From index date up to 5 years of 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 30 Oct 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, run by Sanofi at 1 site in Italy.
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 3 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 30 Oct 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 Italy. 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?
Major Adverse Cardiovascular Events (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 30 Oct 2026.