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

NCT ID: NCT05118230

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-09
• Study Completion Date: 2024-07-20

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.

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.

Conditions

Primary Hypercholesterolemia; Mixed Dyslipidemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Inclisiran Cohort

patients treated with inclisiran in certain special territories in China

Inclisiran

Intervention Type: 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.

SoC Historical Cohort

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

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Haikou, Hainan, China

Novartis Investigative Site

Qionghai, Hainan, China

Countries

China

Other Identifiers

CKJX839A1CN01

Identifier Type: -

Identifier Source: org_study_id