Status:
RECRUITING
Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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 l...
Detailed Description
The study is a multicenter, randomized, parallel, open-label, pragmatic trial, to assess the effectiveness of inclisiran in the real-world compared to SoC, in patients with CHD in China who did not ac...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
1590 Patients enrolled
Trial Details
Trial ID
NCT06941792
Start Date
June 17 2025
End Date
January 30 2026
Last Update
December 30 2025
Active Locations (20)
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1
Novartis Investigative Site
Anqing, Anhui, China, 246003
2
Novartis Investigative Site
Beijing, Beijing Municipality, China, 102218
3
Novartis Investigative Site
Chongqing, Chongqing Municipality, China, 400010
4
Novartis Investigative Site
Longyan, Fujian, China, 364099