ClinicalTrials.gg
CompletedNCT07905508Updated Oct 29, 2026

A Retrospective Cohort Study Evaluating Major Adverse Cardiovascular Events and Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events (OPTIMUS RISK - Netherlands)

An observational study in Atherosclerotic Cardiovascular Disease, sponsored by Sanofi. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Sanofi · Observational

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
180,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Atherosclerotic Cardiovascular Disease

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03

In context

Atherosclerosis

1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.

This study's enrollment of 180,000 is above the median of 250 across 527 observational studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

- 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.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
180,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Major Adverse Cardiovascular Events

    Composite of nonfatal myocardial infarction, nonfatal ischemic stroke, or all-cause mortality.

    Time frame: From index up to 5 years follow up

Secondary outcomes

  1. Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or Cardiovascular Mortality

    Time frame: From index date up to 5 years of follow-up

  2. Occurrence of Nonfatal Myocardial Infarction

    Time frame: From index date up to 5 years of follow-up

  3. Occurrence of Nonfatal Ischemic Stroke

    Time frame: From index date up to 5 years of follow-up

  4. All-Cause Mortality

    Death due to any cause during follow-up.

    Time frame: From index date up to 5 years of follow-up

  5. Cardiovascular Mortality

    Cardiovascular death during follow-up.

    Time frame: From index date up to 5 years of follow-up

07

Study locations

1 site
  • Sanofi
    Amsterdam, 1105 BP, Netherlands
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2025 to primary completion in Jun 2026, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2026
First posted
Oct 29, 2026
StartActual
Nov 17, 2025
Primary completionActual
Jun 30, 2026
CompletionActual
Jun 30, 2026
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07905508
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Nov 17, 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Oct 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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