Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Novartis

Status

Completed

Conditions

Mixed Dyslipidemia

Primary Hypercholesterolemia

Treatments

Other: Inclisiran

Study type

Observational

Funder types

Industry

Identifiers

NCT05118230

CKJX839A1CN01

Details and patient eligibility

About

This is a multi-center, prospective, comparative and non-interventional cohort study involving two cohorts, one cohort (Inclisiran Cohort) of patients treated with inclisiran in certain special territories in China (eg. Bo'ao Pilot Zone) and the other cohort (SoC Historical Cohort) of patients treated with standard of care (SoC) in routine clinical practice from EMR database.

Full description

This study will utilize real-world data from EMR database to serve as the 'external control'.The purpose of this study is to compare the effectiveness of inclisiran as an add-on therapy (or monotherapy in statin-intolerant cases) in real-world settings, with current SoC in a matched historical cohort of patients who receive SoC in EMR database.

The patients in Inclisiran Cohort will received inclisiran injection (300 mg s.c.) under the guidance of physicians, and based on the approved label, which recommends a second dose on 90 days after the first injection, and then followed by injections every 6 months afterwards until the end of study (EOS). However, the treatment decision and exact visit timepoint will be purely decided by physicians and patients.

Enrollment

61 patients

Sex

All

Ages

18 to 105 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inclisiran Cohort Patients eligible for inclusion in this study must meet all of the following criteria.

Confirmed diagnosis of primary hypercholesterolemia or mixed dyslipidemia
Age ≥ 18 years at baseline
Initiated treatment with inclisiran according to the decision of both physician and patient
Signed informed consent(s) must be obtained prior to participation in the study

SoC Historical Cohort Patients eligible for inclusion in this study must meet all of the following criteria.

Confirmed diagnosis of primary hypercholesterolemia or mixed dyslipidemia, with which reference to LDL-C > 70 mg/dL (1.8 mmol/L)
Age ≥ 18 years
Compliance with the standard lipid-lowering therapy, which is defined as a change from prior lipid-lowering therapy to an optimal lipid-lowering regimen, with the date of compliance with standard lipid-lowering therapy after January 1, 2017 as the index date
With available LDL-C test at baseline, which is defined as the closest LDL-C test to the index date within 6 months prior to the index date
With available LDL-C test on D90 (90±60 days) or D330 (330±90 days) after the index date

Exclusion criteria

Inclisiran Cohort Patients meeting any of the following criteria are not eligible for inclusion in this study.

Treatment with monoclonal antibodies directed towards PCSK9 within 90 days before first visit (V1)
Severe hepatic impairment (Child-Pugh class C)
Severe renal impairment (eGFR ≤ 30 mL/min), and/or on hemodialysis
Participation in any cardiovascular clinical trial, concurrent or within the last 30 days of the baseline
Females who are pregnant or nursing, or who are preparing for pregnancy
Hypersensitivity to the active substance or to any of the excipients of inclisiran solution

SoC Historical Cohort Patients meeting any of the following criteria are not eligible for inclusion in this study.

Treatment with monoclonal antibodies directed towards PCSK9 during research period
Severe hepatic impairment (Child-Pugh class C)
Severe renal impairment, (eGFR ≤ 30 mL/min), and/or on hemodialysis
Participation in any cardiovascular clinical trial during research period
Females who are pregnant or nursing during research period