Inclisiran Effectiveness in China: a Pragmatic Randomized Trial (NCT06941792) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
China1,590 participantsStarted 2025-06-17
Plain-language summary
The current study will be conducted to evaluate the real-world effectiveness of inclisiran relative to standard of care (SoC) in Chinese patients with coronary heart disease (CHD), not only with the low-density lipoprotein cholesterol (LDL-C) change in 1 year, but also the LDL-C Test on Target for 1 year. This study further aims to assess the adherence, treatment patterns and satisfaction, and safety of inclisiran among Chinese patients.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent must be obtained prior to participation in the study
. Documented diagnosis of CHD prior to screening, including acute coronary syndrome (ACS) and chronic coronary syndrome (CCS)
. Aged ≥18 years at randomization
. Despite maximally tolerated statin therapy for ≥4weeks stable using prior to screening, LDL-C result at screening not at goal (≥1.8 mmol/L).
Exclusion criteria
. Received inclisiran during the 2 years prior to the screening.
. Received proprotein convertase subtilisin-kexin type 9 (PCSK9) mabs during the 3 months prior to screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percentage change in low-density lipoprotein cholesterol (LDL-C) level from baseline at 12 months, for the inclisiran group versus the standard of care (SoC) group
. Participating in an interventional trial at enrollment
. Having severe liver disorder (Child-Pugh class C)
. 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.