NCT06941792Active, not recruitingPhase 4
Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
Effectiveness of Inclisiran for Patients With Coronary Heart Disease in China: a Multicenter, Standard of Care-Controlled Pragmatic Randomized Trial
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1590 (actual)
- First submitted
- 6 Mar 2025
- Start date
- 17 Jun 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Coronary artery disease
- NCT number
- NCT06941792
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1590
- From 17 Jun 2025 to the primary completion date, 30 Apr 2027
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Other
- Participating in an interventional trial at enrollment
Who the study is looking for
- 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).
- The maximum tolerated dose of statins also includes patients with statin intolerance or contraindication.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.