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Could a cholesterol drug prevent first heart attacks in High-Risk patients?

NCT ID NCT07615179

Knowledge-focused Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This completed study observed over 4,500 adults with atherosclerotic cardiovascular disease who had never had a heart attack or stroke. Researchers compared those taking alirocumab (a cholesterol-lowering drug) to those not on similar therapy, using real-world data to see if the drug reduced the risk of heart attack, stroke, or death. Because it's observational, it can suggest but not prove whether alirocumab helps prevent these first-time events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
alirocumab
What this could lead to
If this study shows alirocumab reduces heart attacks and strokes, it could support using this drug more broadly in people with artery disease who haven't yet had a major event.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It cannot prove cause and effect, and findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

4,545 people

The number who actually took part.

Started

Feb 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants who initiated treatment with Alirocumab from January 01, 2016 till December 31, 2022.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

atherosclerotic cardiovascular disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerotic cardiovascular disease without prior ischemic events

Contacts and locations

Locations

  • Sanofi

    Bridgewater, New Jersey, 08807, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.