Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New drug inclisiran aims to lower cholesterol better in chinese heart patients

NCT ID NCT06941792

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests whether inclisiran, a newer cholesterol-lowering drug, works better than standard treatments for Chinese patients with coronary heart disease. About 1,590 adults whose cholesterol is still high despite statins will receive either inclisiran or usual care. The main goal is to see how much LDL cholesterol drops after one year and how many patients reach their target levels.

What this could mean

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

Active substance
inclisiran
What this could lead to
If it works, this could offer a more effective way to control cholesterol and reduce heart disease risk in Chinese patients.
What could go wrong
This is a phase 4 trial, so inclisiran is already approved; the main question is how it performs in real-world Chinese patients. It may not show a big advantage over standard care, and side effects are possible.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,590 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

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.

Ages

18 to 99 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. Signed informed consent must be obtained prior to participation in the study 2. Documented diagnosis of CHD prior to screening, including acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) 3. Aged ≥18 years at randomization 4. Despite maximally tolerated statin therapy for ≥4weeks stable using prior to screening, LDL-C result at screening not at goal (≥1.8 mmol/L). The maximum tolerated dose of statins also includes patients with statin intolerance or contraindication. Exclusion Criteria: 1. Received inclisiran during the 2 years prior to the screening. 2. Received proprotein convertase subtilisin-kexin type 9 (PCSK9) mabs during the 3 months prior to screening. 3. Participating in an interventional trial at enrollment 4. Having severe liver disorder (Child-Pugh class C) 5. Any other condition that may put the participant at significant risk if the participant participate in the current study, according to investigator's (or delegate's) judgment. Other protocol-defined inclusion/exclusion criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Coronary heart disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Novartis Investigated Site

    Taiyuan, Shanxi, 030000, China

  • Novartis Investigative Site

    Anqing, Anhui, 246003, China

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 102218, China

  • Novartis Investigative Site

    Chongqing, Chongqing Municipality, 400010, China

  • Novartis Investigative Site

    Longyan, Fujian, 364099, China

  • Novartis Investigative Site

    Jiamusi, Heilongjiang, 154002, China

  • Novartis Investigative Site

    Zhengzhou, Henan, 451400, China

  • Novartis Investigative Site

    Baotou, Inner Mongolia, 014010, China

  • Novartis Investigative Site

    Shenyang, Liaoning, 110016, China

  • Novartis Investigative Site

    Shenyang, Liaoning, 121100, China

  • Novartis Investigative Site

    Jining, Shandong, 272000, China

  • Novartis Investigative Site

    Weifang, Shandong, 261000, China

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200065, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610031, China

  • Novartis Investigative Site

    Ürümqi, Xinjiang Uygur Autonomous Region, 830054, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310007, China

  • Novartis Investigative Site

    Jinhua, Zhejiang, 321000, China

  • Novartis Investigative Site

    Ningbo, Zhejiang, 315000, China

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000, China

More trials for these conditions

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