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

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.

Study Overview

• Status: Recruiting
• Conditions: Mixed Dyslipidemia; Primary Hypercholesterolemia
• Intervention / Treatment: Other: Inclisiran

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 570208
      • Recruiting
      • Novartis Investigative Site
    • Qionghai, Hainan, China, 571437
      • Recruiting
      • Novartis Investigative Site
    • Qionghai, Hainan, China
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients who receive inclisiran in authorized health institutions and eligible patients from EMR database.

Description

Inclusion Criteria:

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

1. Confirmed diagnosis of primary hypercholesterolemia or mixed dyslipidemia
2. Age ≥ 18 years at baseline
3. Initiated treatment with inclisiran according to the decision of both physician and patient
4. 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.

1. Confirmed diagnosis of primary hypercholesterolemia or mixed dyslipidemia, with which reference to LDL-C > 70 mg/dL (1.8 mmol/L)
2. Age ≥ 18 years
3. 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
4. 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
5. 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.

1. Treatment with monoclonal antibodies directed towards PCSK9 within 90 days before first visit (V1)
2. Severe hepatic impairment (Child-Pugh class C)
3. Severe renal impairment (eGFR ≤ 30 mL/min), and/or on hemodialysis
4. Participation in any cardiovascular clinical trial, concurrent or within the last 30 days of the baseline
5. Females who are pregnant or nursing, or who are preparing for pregnancy
6. 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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inclisiran Cohort; patients treated with inclisiran in certain special territories in China	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.
SoC Historical Cohort; patients treated with standard of care (SoC) in routine clinical practice from EMR database

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in LDL-C from baseline	To assess the real-world effectiveness of inclisiran plus SoC in reducing LDL-C in reference to a matched historical cohort of SoC.	Baseline, Day 330

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL-C from baseline	Percentage and absolute change will be provided	Baseline, Day 90, Day 150, Day 270, Day 330,Day 450 and Day 510
Change in total cholesterol, HDL-C, Lp(a) and triglycerides from baseline	Percentage and absolute change will be provided	Baseline, Day 90, Day 150, Day 270, Day 330, Day 450 and Day 510
Proportion of patients discontinuing from inclisiran during the study and the reasons for treatment discontinuation if available	If the planned dose is missed for more than 3 months, the patient is considered as discontinuation.	Day 150
Proportion of patients with treatment switch and reinitiation during the study	Switch: defined as patient starts monoclonal antibody treatment directed towards PCSK9. Switching date is defined as the date of the first claim of the new therapy.; Reinitiation: defined as patient previously discontinues inclisiran > 9 months (from last dose received), and then reinitiates inclisiran.	Day 150

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: China; Real World Effectiveness; Inclisiran; Primary Hypercholesterolemia; Mixed Dyslipidemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: CKJX839A1CN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO