Clinical trial NCT05118230: Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hypercholesterolemia
Mixed Dyslipidemia
Keywords: Primary Hypercholesterolemia
Mixed Dyslipidemia
Real World Effectiveness
Inclisiran
China
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-11-11
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Percentage change in LDL-C from baseline
timeFrame: Baseline, Day 330
Secondary outcomes:
measure: Change in LDL-C from baseline
timeFrame: Baseline, Day 90, Day 150, Day 270, Day 330,Day 450 and Day 510
measure: Change in total cholesterol, HDL-C, Lp(a) and triglycerides from baseline
timeFrame: Baseline, Day 90, Day 150, Day 270, Day 330, Day 450 and Day 510
measure: Proportion of patients discontinuing from inclisiran during the study and the reasons for treatment discontinuation if available
timeFrame: Day 150
measure: Proportion of patients with treatment switch and reinitiation during the study
timeFrame: Day 150
Other outcomes:
Locations:
city: Haikou
country: China
facility: Novartis Investigative Site
state: Hainan
city: Qionghai
country: China
facility: Novartis Investigative Site
state: Hainan
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: