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NCT Number: NCT06941792

Inclisiran Effectiveness in China: a 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Anqing, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

inclisiran sodium injection

Drug

After randomization, patients in the inclisiran group will receive inclisiran sodium injection

Standard of care

Combination Product

After randomization switching to or adding on another/other lipid-lowering therapies

Primary outcomes

  1. 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

    Time frame: 12 months

    To evaluate the real-world effectiveness of inclisiran, on the change in LDL-C levels at Month 12, compared with SoC, in Chinese patients with coronary heart disease (CHD)

Secondary outcomes

  1. The proportion of participants with the 1-year LDL-C Test on Target ≥75%, for the inclisiran group versus the SoC group

    Time frame: 12 months

    To evaluate the real-world effectiveness of inclisiran, on the LDL-C Test on Target at Month 12, compared with SoC, in Chinese patients with CHD

  2. 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

    Time frame: At Month 3, Month 6 and Month 9

    To evaluate the effectiveness of inclisiran on the change in LDL-C levels at Month 3, Month 6, and Month 9, compared with SoC

  3. The proportion of participants with LDL-C <1.8 mmol/L at 12 months, for the inclisiran group versus the SoC group

    Time frame: 12 months

    To evaluate the effectiveness of inclisiran on LDL-C at goal at Month 12

  4. To describe LDL-C Test on Target value during the 12 months after baseline, for the inclisiran group and the SoC group.

    Time frame: 12 months

    To evaluate the real-world effectiveness of inclisiran, on LDL-C Test on Target at 1 year, compared with the SoC group.

  5. 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

    Time frame: At Month 3, Month 6, Month 9, and Month 12

    To evaluate the effectiveness of inclisiran on the change in other parameters of the lipid profile at Month 3, Month 6, Month 9, and Month 12, compared with SoC

  6. 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

    Time frame: Baseline, 12 months

    To evaluate the accumulated LDL-C in the inclisiran group and the SoC group

  7. 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

    Time frame: At Month 3, Month 6, Month 9, and Month 12

    To estimate the adherence to inclisiran and other non-statin lipid-lowering therapies (LLTs), as measured by the proportion of days covered (PDC), using prescription data

  8. 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

    Time frame: At Month 3, Month 6, Month 9, and Month 12

    To estimate the adherence to inclisiran and other non-statin lipid-lowering therapies (LLTs), as measured by the proportion of days covered (PDC), using prescription data

  9. 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

    Time frame: At Month 3, Month 6, Month 9, and Month 12

    To estimate the adherence to inclisiran and other non-statin lipid-lowering therapies (LLTs), as measured by the proportion of days covered (PDC), using prescription data

  10. Age at randomization and age at first diagnosis of CHD

    Time frame: 12 months

    To describe the demographics and clinical characteristics of the inclisiran group and the SoC group.

  11. Sex

    Time frame: 12 months

    To describe the demographics and clinical characteristics of the inclisiran group and the SoC group

  12. Temperature

    Time frame: 12 months

    To describe the demographics and clinical characteristics of the inclisiran group and the SoC group

  13. Respiratory rate

    Time frame: 12 months

    To describe the vital signs characteristics of inclisiran group and the SoC group. It will be measured manually or with an electrocardiogram monitor.

  14. Blood pressure

    Time frame: 12 months

    To describe the demographics and clinical characteristics of the inclisiran group and the SoC group

  15. Heart rate

    Time frame: 12 months

    To describe the demographics and clinical characteristics of the inclisiran group and the SoC group

  16. Previous lipid-lowering therapies (LLTs), through Adherence Assessment Questionnaire (AAQ)

    Time frame: 12 months

    The AAQ is a generic instrument for assessing non-adherence (NA) in chronic conditions, consists of 11 items in total. Ten of these items are phrased as statements and use a 4-point Likert scale, offering the response options: Strongly agree, Generally agree, Generally disagree, and Strongly disagree. Each item is scored from 1 to 4, with a higher score indicating a greater likelihood of non-adherence.

  17. Previous lipid-lowering therapies (LLTs), through Adherence Barriers Questionnaire (ABQ)

    Time frame: 12 months

    The ABQ consists of 16 items, each addressing a specific adherence barrier. All items are formulated as statements. A 4-point Likert scale is used, deliberately omitting a neutral response option to encourage decisive answers. The available response options are: Strongly agree, Generally agree, Generally disagree, and Strongly disagree. Each response is assigned a value from 1 to 4 or 4 to 1, depending on the wording of the item, ensuring that a higher score reflects a stronger influence of a specific barrier on the patient's perception. The total score ranges from 16 (minimum) to 64 (maximum).Based on patient responses, both a general ABQ score and item- or subscale-specific scores can be calculated, indicating the number and strength of adherence barriers experienced by a patient.

  18. Dose, frequency, and treatment duration of inclisiran in the inclisiran group and of other LLTs in the SoC group

    Time frame: 12 months

    To describe the treatment patterns of inclisiran and other LLTs

  19. LDL-C variability in the inclisiran group by average successive variability (ASV), coefficient of variation (CV), and variation independent of mean (VIM)

    Time frame: 12 months

    To evaluate LDL-C variability in the inclisiran group

  20. Subsequent LLTs for participants who discontinued/switched the assigned treatment

    Time frame: 12 months

    To describe the treatment patterns of inclisiran and other LLTs

  21. Concomitant lipid lowering treatments

    Time frame: 12 months

    To describe the treatment patterns of inclisiran and other LLTs

  22. Treatment satisfaction from Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: At Month 6 and Month 12

    This scale includes four dimensions: drug treatment effectiveness, adverse reactions, convenience, and overall satisfaction. Whether the patient has experienced adverse drug reactions is scored using "yes" and "no"; The adverse reaction dimension is evaluated using a Likert-5 scale, with scores ranging from 1 to 5 indicating "extremely dissatisfied" to "not dissatisfied at all"; The effectiveness, convenience, and overall satisfaction are rated on a Likert-7 scale, with scores ranging from 1 to 7 indicating "extremely dissatisfied" and "extremely satisfied", respectively. The standard score for each dimension is 100 points, and the higher the score, the higher the patient's satisfaction with drug treatment.

  23. 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

    Time frame: At Month 3, Month 6, Month 9, and Month 12

    To assess treatment satisfaction and adherence by questionnaires

  24. Incidence of adverse events (AEs), serious adverse events (SAEs)

    Time frame: 12 months

    To evaluate the safety of Inclisiran

  25. Number of participants with relevant medical history

    Time frame: 12 months

    To describe the demographics and clinical characteristics of the inclisiran group and the SoC group

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Effectiveness of Inclisiran for Patients With Coronary Heart Disease in China: a Multicenter, Standard of Care-Controlled Pragmatic Randomized Trial

Acronym: V-INVINCIBLE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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