HypercholesterolemiaNCT06595069
A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients
An observational study of Hypercholesterolemia, run by Novartis at 1 site in United States.
Trial summary
This was a single-center, retrospective, observational study (non-interventional study with secondary use of data) among patients in a real-world setting. This study used the medical record data from patients in Yiling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 10 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Received at least one inclisiran injection during the indexing period.
- Had at least 9 months of follow-up from the index date (had at least one LDL-C assessment during baseline period and at least one LDL-C assessment at 9 months or later).
- Patients signed the informed consent form.
Who cannot join
- Participated in any blinded interventional clinical studies anytime during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Retrospective, Observational Study to Assess the Characteristics and the Real-World Long-Term Effectiveness of Inclisiran in Chinese Adult Patients
This was a single-center, retrospective, observational study (non-interventional study with secondary use of data) among patients in a real-world setting.
This study used the medical record data from patients in Yiling. Eligible patients who newly initiated inclisiran from 26 January 2022 to 21 August 2023 were included. The retrospective data up to the date of ethics committee approval (April 2024) was collected. The study team collected patient data using an electronic case report form (eCRF) from April 2024 to June 2024.
- Conditions
- Hypercholesterolemia
- Keywords
- Elevated low-density lipoprotein cholesterol, Inclisiran, Real-world
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran Cohort | Chinese adult patients who received at least one treatment with inclisiran. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
Measured: Baseline, Month 9
Secondary outcomes (15)
Absolute Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
Measured: Baseline, Month 9
Change From Baseline to Month 9 in Total Cholesterol Levels
Measured: Baseline, Month 9
Change From Baseline to Month 9 in Apolipoprotein B Levels
Measured: Baseline, Month 9
Change From Baseline to Month 9 in non-High Density Lipoprotein Cholesterol Levels
Measured: Baseline, Month 9
Change From Baseline to Month 9 in Serum Apolipoprotein A1 Levels
Measured: Baseline, Month 9
Change From Baseline to Month 9 in High Density Lipoprotein Cholesterol Levels
Measured: Baseline, Month 9
Change From Baseline to Month 9 in Lipoprotein (a) Levels
Measured: Baseline, Month 9
Change From Baseline to Month 9 in Triglyceride Levels
Measured: Baseline, Month 9
Number of Patients With at Least two Doses of Inclisiran After the First Injection of Inclisiran
Measured: Up to 27 months
Number of Patients who Switched at Least Once From Inclisiran to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Monoclonal Antibody Treatment
Measured: Up to 27 months
Number of Patients With Changes in Lipid-lowering Therapies (LLTs)
Changes in LLTs included:
- LLT dose modification (dose increase, dose decrease).
- LLT switches.
- Use of new add-on therapy.
- LLT interruption.
- LLT discontinuation.
- Time between first inclisiran injection and subsequent doses.
Measured: Up to 27 months
Proportion of Days Covered (Adherence) of Inclisiran Over 12 Months
Proportion of Days Covered of inclisiran over 12 months was calculated by the days covered by inclisiran within 12 months divided by 12 months.
Measured: 12 months
Number of Patients per Demographic Category
Demographic categories included:
- Age
- Gender
- Ethnicity
- Smoking history
- Alcohol use history
Measured: Baseline
Number of Patients per Clinical Characteristic Category
Clinical characteristics included:
- Family history of hereditary disease
- Comorbidities
- Medication history
- Concomitant medications and/or therapies
- Background LLT regimens
Measured: Baseline
Baseline Lipid Levels
Lipids included, but were not limited to, LDL-C, total cholesterol, apolipoprotein B, non-high density lipoprotein cholesterol, serum apolipoprotein A1, high density lipoprotein cholesterol, lipoprotein (a), and triglycerides.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Apr 2024
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595069
- Sponsor's protocol ID
- CKJX839A1CN05
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Retrospective, Observational Study to Assess the Characteristics and the Real-World Long-Term Effectiveness of Inclisiran in Chinese Adult Patients
- ClinicalTrials.gov ID
- NCT06595069
- Acronym / sponsor ID
- CKJX839A1CN05
- Conditions
- Hypercholesterolemia
- Keywords
- Elevated low-density lipoprotein cholesterol, Inclisiran, Real-world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 19 Sep 2024 (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 was a single-center, retrospective, observational study (non-interventional study with secondary use of data) among patients in a real-world setting.
This study used the medical record data from patients in Yiling. Eligible patients who newly initiated inclisiran from 26 January 2022 to 21 August 2023 were included. The retrospective data up to the date of ethics committee approval (April 2024) was collected. The study team collected patient data using an electronic case report form (eCRF) from April 2024 to June 2024.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inclisiran Cohort | – | –Chinese adult patients who received at least one treatment with inclisiran. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (3 listed)
- Received at least one inclisiran injection during the indexing period.
- Had at least 9 months of follow-up from the index date (had at least one LDL-C assessment during baseline period and at least one LDL-C assessment at 9 months or later).
- Patients signed the informed consent form.
Key exclusion criteria (1 listed)
- Participated in any blinded interventional clinical studies anytime during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
Time frame: Baseline, Month 9
15 secondary outcomes
Absolute Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in Total Cholesterol Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in Apolipoprotein B Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in non-High Density Lipoprotein Cholesterol Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in Serum Apolipoprotein A1 Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in High Density Lipoprotein Cholesterol Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in Lipoprotein (a) Levels
Time frame: Baseline, Month 9
Change From Baseline to Month 9 in Triglyceride Levels
Time frame: Baseline, Month 9
Number of Patients With at Least two Doses of Inclisiran After the First Injection of Inclisiran
Time frame: Up to 27 months
Number of Patients who Switched at Least Once From Inclisiran to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Monoclonal Antibody Treatment
Time frame: Up to 27 months
Number of Patients With Changes in Lipid-lowering Therapies (LLTs)
Time frame: Up to 27 months
Proportion of Days Covered (Adherence) of Inclisiran Over 12 Months
Time frame: 12 months
Number of Patients per Demographic Category
Time frame: Baseline
Number of Patients per Clinical Characteristic Category
Time frame: Baseline
Baseline Lipid Levels
Time frame: Baseline
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 19 Sep 2024.
Related trials for Hypercholesterolemia
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Polygenic Hypercholesterolaemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Novartis at 1 site in United States.
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 3 inclusion and 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels (time frame: Baseline, Month 9). 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 19 Sep 2024.