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Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

Active Not RecruitingPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Coronary Heart Disease

Interventions: inclisiran sodium injection, Standard of Care

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (19)

Anqing, Anhui, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Longyan, Fujian, China
Jiamusi, Heilongjiang, China
Zhengzhou, Henan, China
Baotou, Inner Mongolia, China
Shenyang, Liaoning, China
Shenyang, Liaoning, China
Jining, Shandong, China
Weifang, Shandong, China
Shanghai, Shanghai Municipality, China
Taiyuan, Shanxi, China
Chengdu, Sichuan, China
Ürümqi, Xinjiang Uygur Autonomous Region, China
Hangzhou, Zhejiang, China
Jinhua, Zhejiang, China
Ningbo, Zhejiang, China
Wenzhou, Zhejiang, China