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

A Prospective, Observational Study to Assess the Real World Effectiveness of Inclisiran (Leqvio®) in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

ClinicalTrials.gov Identifier: NCT05118230

Novartis Reference Number: CKJX839A1CN01

Last Update: May 17, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Primary Hypercholesterolemia
Mixed Dyslipidemia
Phase 
Not Given
Overall status 
Recruiting
Start date 
Dec 09, 2021
Completion date 
Sep 30, 2024
Gender 
All
Age(s)
18 Years - 105 Years (Adult, Older Adult)

Interventions

Other
Inclisiran
Prospective observational study. There is no treatment allocation. Chinese Patients who receive inclisiran in authorized health institutions are eligible to enroll into this study.

Eligibility Criteria

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

Study Locations

China
Novartis Investigative Site
Recruiting
Haikou, 570208
Hainan
China
Novartis Investigative Site
Recruiting
Qionghai,
Hainan
China

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]