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Can Extra-Strength statins stop heart attacks before they start?

NCT ID NCT05462262

Disease control Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Updated 3 times

Summary

This study tests whether stronger cholesterol-lowering drugs (atorvastatin plus ezetimibe) can slow the growth of artery plaque and reduce heart attacks, strokes, and other heart problems in adults aged 40–75 who have early plaque but are only at low-to-moderate risk. About 2,900 participants will be randomly assigned to either intensive or standard cholesterol treatment and followed for several years. The goal is to see if a more aggressive approach prevents heart events better than current standard care.

What this could mean

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

Active substance
atorvastatin and ezetimibe
What this could lead to
If successful, this could show that more aggressive cholesterol lowering helps prevent heart attacks and strokes in people with early plaque buildup.
What could go wrong
This is an open-label trial, so results may be biased. The benefit may be small, and intensive therapy can cause muscle pain or liver issues.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 to 75 years

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: 1. Age 40-75 years 2. Low to Intermediate 10-year atherosclerotic cardiovascular disease (ASCVD) risk using pooled cohort equations (PCE). 3. Coronary CT angiography shows atherosclerotic plaque in the main coronary vessels (\>2mm diameter) with luminal stenosis \<70% Exclusion Criteria: 1. Combination with serious cardiovascular diseases, including 1. Heart failure (ejection fraction \<30%) 2. Arrhythmias (persistent atrial flutter/atrial fibrillation, second-degree or third-degree atrioventricular block) 3. Hemodynamically important valvular disease 4. Hemodynamically important congenital heart disease 5. Stroke 2. Myocardial infarction, coronary revascularization, or severe/unstable angina before or within 1 month of screening 3. Active liver disease or hepatic dysfunction (defined as alanine aminotransferase or aspartate aminotransferase\> 3 times the upper limit of normal) 4. Unexplained creatine phosphokinase\> 6 times the upper limit of normal 5. Nephrotic syndrome 6. Diabetes mellitus 7. Uncontrollable hypertension 8. Uncontrollable hypothyroidism 9. Hypersensitivity to statins 10. Any planned surgical procedure for the treatment of atherosclerosis 11. Gastrointestinal diseases affecting drug absorption or history of gastrointestinal surgery 12. Survival-limiting diseases 13. Concurrent long-term immunosuppressive therapy 14. Participation in another clinical trial concurrently or within 30 days before screening 15. Pregnant or breastfeeding 16. Other unsuitable situations deemed by physicians

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease progression

Contacts and locations

Locations

  • Fuwai Hospital

    Beijing, Beijing Municipality, China

More trials for these conditions

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