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

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.

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 achieve LDL-C goal despite maximally tolerated statin therapy for ≥4weeks stable using. CHD patients include patients with acute coronary syndrome and patients with chronic coronary syndrome.

After granting informed consent, being screened, and confirmed eligible for the study, participants will be randomized to 2 arms (inclisiran or SoC) in a 1:1 ratio.

Following the randomization, participants start inclisiran or SoC adaptation (which means switching to or adding on another/other lipid-lowering therapies (LLT[s]). This start date is defined as Day 0.

During follow-up, each participant will follow routine care, and the results of LDL-C tests will be collected for each Visit (every 3 months), with an allowable window of ±1.5 months. Each patient will be followed up until his/her end of study (EOS), which is the earliest of the end of follow-up period (Visit 4: approximately 12 months following Day 0), lost to follow-up, consent withdrawal, death, and participating in another interventional trial.

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.