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

NCT05118230 | Completed

• 1 other identifier: CKJX839A1CN01
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Primary Hypercholesterolemia; Mixed Dyslipidemia

Keywords

Primary Hypercholesterolemia; Mixed Dyslipidemia; Real World Effectiveness; Inclisiran; China

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in LDL-C from baseline

  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

  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

  Day 150

• Proportion of patients with treatment switch and reinitiation during the study

  Day 150

Study Arms (2)

Inclisiran Cohort

patients treated with inclisiran in certain special territories in China

Other: Inclisiran

SoC Historical Cohort

patients treated with standard of care (SoC) in routine clinical practice from EMR database

Interventions

Inclisiran OTHER

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

Inclisiran Cohort

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Haikou, Hainan, 570208, China

Location

Novartis Investigative Site

Qionghai, Hainan, 571437, China

Location

MeSH Terms

Interventions

ALN-PCS

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 11, 2021
• Study Start: December 9, 2021
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)