Clinical trial NCT06941792: Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
Official title: Effectiveness of Inclisiran for Patients With Coronary Heart Disease in China: a Multicenter, Standard of Care-Controlled Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Coronary Heart Disease
Keywords: Inclisiran
effectiveness
lipid-lowering
low-density lipoprotein cholesterol Test on Target
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-04-24
Enrollment: 1590
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

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.

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: The proportion of participants with the 1-year LDL-C Test on Target ≥75%, for the inclisiran group versus the SoC group
timeFrame: 12 months
measure: The percentage change in LDL-C level from baseline at 3 months, 6 months, and 9 months, for the inclisiran group versus the SoC group
timeFrame: At Month 3, Month 6 and Month 9
measure: The proportion of participants with LDL-C <1.8 mmol/L at 12 months, for the inclisiran group versus the SoC group
timeFrame: 12 months
measure: To describe LDL-C Test on Target value during the 12 months after baseline, for the inclisiran group and the SoC group.
timeFrame: 12 months
measure: The percentage change in levels of total cholesterol, triglyceride, HDL-C, Lp(a), ApoA, and ApoB, from baseline at 3 months, 6 months, 9 months, and 12 months, for the inclisiran group versus the SoC group
timeFrame: At Month 3, Month 6, Month 9, and Month 12
measure: Area under the curve (AUC) of LDL-C level versus time (from 0 months to 12 months), for the inclisiran group versus the SoC group
timeFrame: Baseline, 12 months
measure: The proportion of participants with PDCinclisiran≥80% in the inclisiran group and the proportion of participants with PDCnon-statin≥80% in the SoC group, at 3 months, 6 months, 9 months, and 12 months
timeFrame: At Month 3, Month 6, Month 9, and Month 12
measure: The average number of days covered, of inclisiran in the inclisiran group and of non-statin lipid-lowering therapies (LLTs) in the SoC group, at 3 months, 6 months, 9 months, and 12 months
timeFrame: At Month 3, Month 6, Month 9, and Month 12
measure: The average PDCinclisiran in the inclisiran group and the average PDCnon-statin in the SoC group, at 3 months, 6 months, 9 months, and 12 months
timeFrame: At Month 3, Month 6, Month 9, and Month 12
measure: Age at randomization and age at first diagnosis of CHD
timeFrame: 12 months
measure: Sex
timeFrame: 12 months
measure: Temperature
timeFrame: 12 months
measure: Respiratory rate
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Heart rate
timeFrame: 12 months
measure: Previous lipid-lowering therapies (LLTs), through Adherence Assessment Questionnaire (AAQ)
timeFrame: 12 months
measure: Previous lipid-lowering therapies (LLTs), through Adherence Barriers Questionnaire (ABQ)
timeFrame: 12 months
measure: Dose, frequency, and treatment duration of inclisiran in the inclisiran group and of other LLTs in the SoC group
timeFrame: 12 months
measure: LDL-C variability in the inclisiran group by average successive variability (ASV), coefficient of variation (CV), and variation independent of mean (VIM)
timeFrame: 12 months
measure: Subsequent LLTs for participants who discontinued/switched the assigned treatment
timeFrame: 12 months
measure: Concomitant lipid lowering treatments
timeFrame: 12 months
measure: Treatment satisfaction from Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: At Month 6 and Month 12
measure: The average PDCinclisiran in the inclisiran group and the average PDCnon-statin in the SoC group, from patient questionnaire data, at 3 months, 6 months, 9 months, and 12 months
timeFrame: At Month 3, Month 6, Month 9, and Month 12
measure: Incidence of adverse events (AEs), serious adverse events (SAEs)
timeFrame: 12 months
measure: Number of participants with relevant medical history
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: