New drug inclisiran aims to lower cholesterol better in chinese heart patients
NCT ID NCT06941792
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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1,590 people
The number who actually took part.
- Started
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Jun 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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
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Novartis Investigated Site
Taiyuan, Shanxi, 030000, China
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Novartis Investigative Site
Anqing, Anhui, 246003, China
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Novartis Investigative Site
Beijing, Beijing Municipality, 102218, China
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Novartis Investigative Site
Chongqing, Chongqing Municipality, 400010, China
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Novartis Investigative Site
Longyan, Fujian, 364099, China
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Novartis Investigative Site
Jiamusi, Heilongjiang, 154002, China
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Novartis Investigative Site
Zhengzhou, Henan, 451400, China
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Novartis Investigative Site
Baotou, Inner Mongolia, 014010, China
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Novartis Investigative Site
Shenyang, Liaoning, 110016, China
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Novartis Investigative Site
Shenyang, Liaoning, 121100, China
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Novartis Investigative Site
Jining, Shandong, 272000, China
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Novartis Investigative Site
Weifang, Shandong, 261000, China
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Novartis Investigative Site
Shanghai, Shanghai Municipality, 200065, China
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Novartis Investigative Site
Chengdu, Sichuan, 610031, China
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Novartis Investigative Site
Ürümqi, Xinjiang Uygur Autonomous Region, 830054, China
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Novartis Investigative Site
Hangzhou, Zhejiang, 310007, China
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Novartis Investigative Site
Jinhua, Zhejiang, 321000, China
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Novartis Investigative Site
Ningbo, Zhejiang, 315000, China
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Novartis Investigative Site
Wenzhou, Zhejiang, 325000, China
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