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Can extremely low cholesterol save more hearts? new trial aims to find out

NCT ID NCT07615296

Disease control Sponsor: Beijing Anzhen 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two cholesterol-lowering strategies in 6,000 Chinese patients with very high-risk heart disease. One group aims for ultra-low LDL cholesterol below 1.0 mmol/L, while the other targets a moderate level of 1.0-1.39 mmol/L. Researchers will track heart attacks, strokes, and deaths over up to 5 years, along with safety and cost. The goal is to see if pushing cholesterol extremely low offers extra protection without unacceptable side effects.

What this could mean

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

Active substance
Lipid-lowering therapy (statins, ezetimibe, PCSK9 inhibitors)
What this could lead to
If successful, this could show that pushing LDL cholesterol extremely low provides better protection against heart attacks and strokes for high-risk patients, potentially changing treatment guidelines.
What could go wrong
This is an early-stage trial with no results yet. Ultra-low LDL-C may increase risks like cognitive decline or bleeding, and the benefit may not outweigh these risks. The study is also limited to Chinese patients, so results may not apply globally.

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 6,000 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2031

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

18 to 80 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. Aged 18-80 years, any sex. 2. Diagnosed with ultra-high-risk ASCVD per 2023 Chinese Lipid Guidelines: either ≥2 major ASCVD events within 24 months, or 1 major ASCVD event plus ≥2 high-risk factors (diabetes, multi-vessel disease, premature CHD family history, elevated Lp(a), hypertension). 3. LDL-C ≥1.0 mmol/L after ≥4-week maximum-tolerated statin plus ezetimibe therapy, confirmed by central laboratory. 4. Able to complete follow-up and examinations; no severe hepatic/renal dysfunction. 5. Voluntary participation with written informed consent. Exclusion Criteria: 1. Hypersensitivity or intolerance to statins, ezetimibe, or PCSK9 inhibitors. 2. Hemorrhagic stroke, active bleeding, severe trauma or major surgery within 6 months before enrollment. 3. Malignancy (expected survival \<3 years), severe liver/kidney disease, or autoimmune disease. 4. Cognitive impairment (MoCA \<20) or psychiatric disorders precluding assessment cooperation. 5. Pregnant, breastfeeding, or planning pregnancy during the trial. 6. Participation in other clinical trials or use of other lipid-lowering drugs within 3 months. 7. Poor compliance or other conditions judged by investigators to interfere with the study.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease

As listed by the trial registrant

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

Atherosclerotic cardiovascular disease (ascvd)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029, China

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