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

Primary Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05118230
• Other study ID #: CKJX839A1CN01
• Status: Active, not recruiting
• Start date: December 9, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia
• Mixed Dyslipidemia
• Primary Hypercholesterolemia

Intervention

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.

Locations

Country	Name	City	State
China	Novartis Investigative Site	Haikou	Hainan
China	Novartis Investigative Site	Qionghai	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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