Primary HypercholesterolemiaNCT05118230
Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
An observational study of Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- What is being tested?
- Inclisiran
- How many people
- 61 participants
- Where
- 2 sitesChina
- Study dates
- 9 Dec 2021to 20 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients who receive inclisiran in authorized health institutions and eligible patients from EMR database.
Who may be able to join
- Inclisiran Cohort Patients eligible for inclusion in this study must meet all of the following criteria.
- 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
- SoC Historical Cohort Patients eligible for inclusion in this study must meet all of the following criteria.
Show all 11Show fewer
- 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
Who cannot join
- Inclisiran Cohort Patients meeting any of the following criteria are not eligible for inclusion in this study.
- 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
Show all 13Show fewer
- 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.
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Novartis Investigative Site
Haikou, Hainan, 570208
Novartis Investigative Site
Qionghai, Hainan, 571437
About this study
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
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.
Read the 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
- Being tested
- Inclisiran
- Keywords
- Primary Hypercholesterolemia, Mixed Dyslipidemia, Real World Effectiveness, Inclisiran, China
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranOther
Prospective observational study. There is no treatment allocation. Chinese Patients who receive inclisiran in authorized health institutions are eligible to enroll into this study.
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran Cohort | patients treated with inclisiran in certain special territories in China Receives: Other: Inclisiran | |
| SoC Historical Cohort | patients treated with standard of care (SoC) in routine clinical practice from EMR database |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 330
Secondary outcomes (4)
Change in LDL-C from baseline
Percentage and absolute change will be provided
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start9 Dec 2021
- Primary completion20 Jul 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118230
- Sponsor's protocol ID
- CKJX839A1CN01
- Status last verified
- Aug 2024
- First submitted
- 26 Oct 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05118230
- Acronym / sponsor ID
- CKJX839A1CN01
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Keywords
- Primary Hypercholesterolemia, Mixed Dyslipidemia, Real World Effectiveness, Inclisiran, China
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inclisiran Cohort | – | Other: Inclisiranpatients treated with inclisiran in certain special territories in China |
| SoC Historical Cohort | – | –patients treated with standard of care (SoC) in routine clinical practice from EMR database |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients who receive inclisiran in authorized health institutions and eligible patients from EMR database.
Key inclusion criteria (11 listed)
- Inclisiran Cohort Patients eligible for inclusion in this study must meet all of the following criteria.
- 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
Key exclusion criteria (13 listed)
- Inclisiran Cohort Patients meeting any of the following criteria are not eligible for inclusion in this study.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InclisiranProspective observational study. There is no treatment allocation. Chinese Patients who receive inclisiran in authorized health institutions are eligible to enroll into this study. | Other | Inclisiran Cohort |
Primary outcome
Percentage change in LDL-C from baseline
Time frame: Baseline, Day 330
To assess the real-world effectiveness of inclisiran plus SoC in reducing LDL-C in reference to a matched historical cohort of SoC.
4 secondary outcomes
Change in LDL-C from baseline
Time frame: 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
Time frame: 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
Time frame: Day 150
Proportion of patients with treatment switch and reinitiation during the study
Time frame: Day 150
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Primary Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in LDL-C from baseline (time frame: Baseline, Day 330). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.