Atherosclerotic Cardiovascular DiseaseNCT06507852
A Real-world Study of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness in ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia
An observational study of Atherosclerotic Cardiovascular Disease and Hypercholesterolemia, run by Novartis at 1 site in United States.
Trial summary
This was a descriptive, non-interventional, retrospective cohort study among patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent (ASCVD-RE) or familial hypercholesterolemia (FH) administered inclisiran in a real-world setting in Austria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, Hypercholesterolemia
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 6 Jul 2023
- 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
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Patients who were 18 years or older.
- Signed informed consent was obtained.
- Patients who received at least one inclisiran injection in the identification period.
- Patients with at least one diagnosis of ASCVD, ASCVD-RE or FH diagnosis prior to index date.
- Patients with at least one low-density lipoprotein cholesterol (LDL-C) measurement of 70 milligrams per deciliter (mg/dL) or greater, within 6 months prior to index date.
- ASCVD was defined as previous diagnosis of coronary artery disease (CAD), peripheral artery disease (PAD) or cerebrovascular disease (CVD).
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- ASCVD-RE was defined as: no previous diagnosis of ASCVD at any time on the patient chart and they met at least one of the following criteria:
- Diagnosis of type II diabetes mellitus (T2DM).
- Diagnosis of type I diabetes mellitus (T1DM) of long duration (greater than 20 years).
- 10-year risk of 20% or greater by Framingham risk score.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Assessment of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness Among ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia Patients Prescribed LEQVIO® (Inclisiran) in a Real-world Setting
This was a descriptive, non-interventional, retrospective cohort study among patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent (ASCVD-RE) or familial hypercholesterolemia (FH) administered inclisiran in a real-world setting in Austria.
- Medical subject headings
- Atherosclerosis, 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 |
|---|---|---|
| Overall Cohort | Adult patients with ASCVD and hypercholesterolemia, ASCVD-RE with hypercholesterolemia, or FH, who were prescribed inclisiran in a real-world setting as per clinical practice and according to the label in Austria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients who Received Inclisiran Dose 2 and 3 Within Specified Time Intervals
Time intervals:
- Time from Dose 1 to Dose 2: 5 months or less.
- Time from Dose 2 to Dose 3:
- Less than 6 months.
- Between 6 months and 9 months.
- Greater than 9 months.
Measured: Up to 26 months
Secondary outcomes (28)
Percentage of Patients Taking Different Concomitant Lipid Lowering Therapy (LLT) at Index Date
Index date was defined as the date of first administration of inclisiran.
Measured: Day 1 of Month 6
Percentage of Patients who Received Inclisiran Doses Within Specified Time Intervals
Time intervals:
- Time from Dose 1 to Dose 2:
- Less than 3.5 months.
- Between 3.5 and 5 months.
- Greater than 5 months.
- Time from Dose 2 to Dose 3:
- Less than 6 months.
- Between 6 and 7 months.
- Between 7 and 8 months.
- Between 8 and 9 months.
- Greater than 9 months.
Measured: Up to 26 months
Gender
Measured: Baseline
Race
Measured: Baseline
Smoking Status
Patient smoker status:
- Non-smoker
- Current smoker
- Past smoker
- Unknown
Measured: Baseline
Physical Activity
Physical activity was classified as intense, light, moderate, or unknown.
Measured: Baseline
Prescribing Physician Specialty
Measured: Baseline
Age
Measured: Baseline
Weight
Measured: Baseline
Height
Measured: Baseline
Body Mass Index
Measured: Baseline
Blood Pressure
Blood pressure: systolic and diastolic.
Measured: Baseline
Percentage of Male Patients by Age Group
Age groups:
- Less than 15 years old.
- 15 to 19 years old.
- 20 to 29 years old.
- 30 to 39 years old.
- 40 to 49 years old.
- 50 to 59 years old.
- 60 years or older.
Measured: Baseline
Percentage of Female Patients by Age Group
Age groups:
- Less than 15 years old.
- 15 to 19 years old.
- 20 to 29 years old.
- 30 to 39 years old.
- 40 to 49 years old.
- 50 to 59 years old.
- 60 years or older.
Measured: Baseline
Percentage of Patients Categorized by Comorbidities
Measured: Baseline
Cholesterol
Cholesterol included:
- Low-density lipoprotein cholesterol.
- High-density lipoprotein cholesterol.
- Non-high-density lipoprotein cholesterol.
- Total cholesterol.
Measured: Baseline
Triglycerides
Measured: Baseline
Apolipoprotein B
Measured: Baseline
Glycated hemoglobin
Measured: Baseline
Lipoprotein(a)
Measured: Baseline
Creatinine
Measured: Baseline
Alanine Aminotransferase
Measured: Baseline
Aspartate Aminotransferase
Measured: Baseline
Alkaline phosphatase
Measured: Baseline
Percentage of Patients With Procedures
Measured: Baseline
Percentage of Atherosclerotic Cardiovascular Disease (ASCVD) Patients Categorized by Qualifying Diagnosis
Qualifying diagnoses were coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease (CVD).
Measured: Baseline
Percentage of ASCVD-risk Equivalent Patients Categorized by Qualifying Criteria
Qualifying Criteria:
- Type II diabetes mellitus.
- Framingham risk score of 20% or greater.
- Type I diabetes mellitus of for more than 20 years.
Measured: Baseline
Percentage of Patients Categorized by Lipid Lowering Therapies (LLTs) Prior to Index Date
Index date was defined as the date of first administration of inclisiran.
Measured: Up to 6 months pre-index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start3 Oct 2022
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies 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
- 95 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
- NCT06507852
- Sponsor's protocol ID
- CKJX839A1AT01
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Assessment of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness Among ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia Patients Prescribed LEQVIO® (Inclisiran) in a Real-world Setting
- ClinicalTrials.gov ID
- NCT06507852
- Acronym / sponsor ID
- CKJX839A1AT01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 18 Jul 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 descriptive, non-interventional, retrospective cohort study among patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent (ASCVD-RE) or familial hypercholesterolemia (FH) administered inclisiran in a real-world setting in Austria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Cohort | – | –Adult patients with ASCVD and hypercholesterolemia, ASCVD-RE with hypercholesterolemia, or FH, who were prescribed inclisiran in a real-world setting as per clinical practice and according to the label in Austria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (10 listed)
- Patients who were 18 years or older.
- Signed informed consent was obtained.
- Patients who received at least one inclisiran injection in the identification period.
- Patients with at least one diagnosis of ASCVD, ASCVD-RE or FH diagnosis prior to index date.
- Patients with at least one low-density lipoprotein cholesterol (LDL-C) measurement of 70 milligrams per deciliter (mg/dL) or greater, within 6 months prior to index date.
Key exclusion criteria (1 listed)
- None.
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 of Patients who Received Inclisiran Dose 2 and 3 Within Specified Time Intervals
Time frame: Up to 26 months
Time intervals: * Time from Dose 1 to Dose 2: 5 months or less. * Time from Dose 2 to Dose 3: * Less than 6 months. * Between 6 months and 9 months. * Greater than 9 months.
28 secondary outcomes
Percentage of Patients Taking Different Concomitant Lipid Lowering Therapy (LLT) at Index Date
Time frame: Day 1 of Month 6
Percentage of Patients who Received Inclisiran Doses Within Specified Time Intervals
Time frame: Up to 26 months
Gender
Time frame: Baseline
Race
Time frame: Baseline
Smoking Status
Time frame: Baseline
Physical Activity
Time frame: Baseline
Prescribing Physician Specialty
Time frame: Baseline
Age
Time frame: Baseline
Weight
Time frame: Baseline
Height
Time frame: Baseline
Body Mass Index
Time frame: Baseline
Blood Pressure
Time frame: Baseline
Percentage of Male Patients by Age Group
Time frame: Baseline
Percentage of Female Patients by Age Group
Time frame: Baseline
Percentage of Patients Categorized by Comorbidities
Time frame: Baseline
Cholesterol
Time frame: Baseline
Triglycerides
Time frame: Baseline
Apolipoprotein B
Time frame: Baseline
Glycated hemoglobin
Time frame: Baseline
Lipoprotein(a)
Time frame: Baseline
Creatinine
Time frame: Baseline
Alanine Aminotransferase
Time frame: Baseline
Aspartate Aminotransferase
Time frame: Baseline
Alkaline phosphatase
Time frame: Baseline
Percentage of Patients With Procedures
Time frame: Baseline
Percentage of Atherosclerotic Cardiovascular Disease (ASCVD) Patients Categorized by Qualifying Diagnosis
Time frame: Baseline
Percentage of ASCVD-risk Equivalent Patients Categorized by Qualifying Criteria
Time frame: Baseline
Percentage of Patients Categorized by Lipid Lowering Therapies (LLTs) Prior to Index Date
Time frame: Up to 6 months pre-index date
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 18 Jul 2024.
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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 Atherosclerotic Cardiovascular Disease and 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 10 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 18 Jul 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 of Patients who Received Inclisiran Dose 2 and 3 Within Specified Time Intervals (time frame: Up to 26 months). 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 18 Jul 2024.