Atherosclerotic Cardiovascular DiseaseBE REALNCT05726838
The Belgian REAL (BE.REAL) Registry
An observational study of Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals.
Trial summary
This is an observational non-interventional study. The visit schedule is according to the routine clinical practice. Only data corresponding to study variables within the specified study period will be collected. The study will recruit patients into one single cohort: Inclisiran in combination with other LLTs. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Inclisiran
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2022to 30 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It will consist of adult ASCVD patients and elevated levels of LDL-C with an initial prescription for Leqvio between 01-May-2022 and 31- Dec-2025, who provided written informed consent.
Who may be able to join
- Patients who are 18 years or older.
- Patients with Atherosclerotic Cardiovascular Disease (ASCVD) who are eligible for commercially available Leqvio, as defined by the reimbursement criteria:
- Patients with ASCVD documented by previous coronary heart disease (CHD), cerebrovascular disease or peripheral artery disease (PAD) and LDL-C ≥ 100mg/dL despite a treatment of min 6 weeks with max tolerated statin (unless intolerance or contra-indication) in combination with ezetimibe (unless intolerance or contra-indication).
- Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD who are eligible for commercially available Leqvio.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Patients who have received Inclisiran previously.
- Patients participating in a clinical trial with investigational product.
- Heterozygous Familial Hypercholesterolemia patients without established Atherosclerotic Cardiovascular Disease.
About this study
Official title: A Belgian Registry to Evaluate the Real Life Treatment With Inclisiran on Top of Standard of Care Lipid-lowering Therapy in Patients With Atherosclerotic Cardiovascular Disease
This is an observational non-interventional study. The visit schedule is according to the routine clinical practice. Only data corresponding to study variables within the specified study period will be collected.
The study will recruit patients into one single cohort: Inclisiran in combination with other LLTs. The patients will receive Inclisiran therapy as per the approved label and Belgian reimbursement conditions.
Read the detailed description
The study aims to assess the effectiveness, safety and adherence for Inclisiran in combination with lipid-lowering therapy (LLT) under conditions of routine clinical practice. The Inclisiran cohort will include patients receiving Inclisiran therapy as per the approved label independently of background Standard of Care (SoC) therapy. This study will include both primary data collection and secondary use of data.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Inclisiran
- Keywords
- NIS, atherosclerotic cardiovascular disease, ASCVD, BE.REAL, BE REAL, inclisiran, Belgium
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranOther
There is no treatment allocation. Patients administered inclisiran by prescription will be enrolled. The patients will receive inclisiran therapy as per the approved label and Belgian reimbursement conditions.
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran | Patients prescribed inclisiran on top of standard of care lipid-lowering therapy Receives: Other: Inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change in LDL-C from baseline
Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline will be collected
Measured: Baseline, up to 39 months
Mean absolute change in LDL-C from baseline
Mean absolute change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline
Measured: Baseline, up to 39 months
Percentage of patients achieving the guideline-recommended LDL-C target at any time
Percentage of patients achieving the guideline-recommended Low-Density Lipoprotein Cholesterol (LDL-C) target at any time will be collected
Measured: Up to 39 months
Secondary outcomes (9)
Percentage of patients maintaining the guideline-recommended LDL-C target
Percentage of patients maintaining the guideline-recommended LDL-C target (once achieved) for the duration of the study will be collected
Measured: Up to 39 months
Time- adjusted percentage change in LDL-C from baseline
time- adjusted percentage change in LDL-C from baseline to 3 months (2nd injection), 9 months (3rd injection), 15 months (4th injection), 21 months (5th injection), 27 months (6th injection), 33 months (7th injection) and 39 months (8th injection)
Measured: Baseline, month 3, month 9, month 15, month 21, month 27, month 33, month 39
Change in LDL-C from baseline stratified on background therapy
Change in LDL-C from baseline stratified on background therapy will be collected
Measured: Baseline, up to 39 months
Percentage of patients remaining on Inclisiran therapy at each injection visit
Percentage of patients remaining on Inclisiran therapy at each injection visit will be collected
Measured: Up to 39 months
Percentage of patients with dose changes, switching, discontinuation
Percentage of patients with dose changes, switching or discontinuation will be collected
Measured: Up to 39 months
Number of ASCVD-related events
Number of atherosclerotic cardiovascular disease (ASCVD)-related events will be collected
Measured: Up to 39 months
Number of possibly related adverse events
Number of possibly related adverse events will be collected
Measured: Up to 39 months
Number of injection site reactions
Number of injection site reactions will be collected
Measured: Up to 39 months
Number of patients with changes in Lp(a) levels for Inclisiran-treated patients
Number of patients with changes in Lipoprotein (a) levels for Inclisiran-treated patients will be collected
Measured: Up to 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start15 Apr 2022
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
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.
- 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
- Other
- Enrolment
- 600 participants (estimated)
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
- NCT05726838
- Sponsor's protocol ID
- CKJX839D1BE01
- Acronym
- BE REAL
- Status last verified
- May 2026
- First submitted
- 3 Feb 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Belgian Registry to Evaluate the Real Life Treatment With Inclisiran on Top of Standard of Care Lipid-lowering Therapy in Patients With Atherosclerotic Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05726838
- Acronym / sponsor ID
- BE REAL / CKJX839D1BE01
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- NIS, atherosclerotic cardiovascular disease, ASCVD, BE.REAL, BE REAL, inclisiran, Belgium
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 14 Feb 2023 (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 an observational non-interventional study. The visit schedule is according to the routine clinical practice. Only data corresponding to study variables within the specified study period will be collected.
The study will recruit patients into one single cohort: Inclisiran in combination with other LLTs. The patients will receive Inclisiran therapy as per the approved label and Belgian reimbursement conditions.
Detailed description
The study aims to assess the effectiveness, safety and adherence for Inclisiran in combination with lipid-lowering therapy (LLT) under conditions of routine clinical practice. The Inclisiran cohort will include patients receiving Inclisiran therapy as per the approved label independently of background Standard of Care (SoC) therapy. This study will include both primary data collection and secondary use of data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inclisiran | – | Other: InclisiranPatients prescribed inclisiran on top of standard of care lipid-lowering therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It will consist of adult ASCVD patients and elevated levels of LDL-C with an initial prescription for Leqvio between 01-May-2022 and 31- Dec-2025, who provided written informed consent.
Key inclusion criteria (5 listed)
- Patients who are 18 years or older.
- Patients with Atherosclerotic Cardiovascular Disease (ASCVD) who are eligible for commercially available Leqvio, as defined by the reimbursement criteria:
- Patients with ASCVD documented by previous coronary heart disease (CHD), cerebrovascular disease or peripheral artery disease (PAD) and LDL-C ≥ 100mg/dL despite a treatment of min 6 weeks with max tolerated statin (unless intolerance or contra-indication) in combination with ezetimibe (unless intolerance or contra-indication).
- Heterozygous Familial Hypercholesterolemia (HeFH) patients with documented ASCVD who are eligible for commercially available Leqvio.
- Patients who provide written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Patients who have received Inclisiran previously.
- Patients participating in a clinical trial with investigational product.
- Heterozygous Familial Hypercholesterolemia patients without established Atherosclerotic Cardiovascular Disease.
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 |
|---|---|---|
| InclisiranThere is no treatment allocation. Patients administered inclisiran by prescription will be enrolled. The patients will receive inclisiran therapy as per the approved label and Belgian reimbursement conditions. | Other | Inclisiran |
Primary outcome
Mean percent change in LDL-C from baseline
Time frame: Baseline, up to 39 months
Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline will be collected
Mean absolute change in LDL-C from baseline
Time frame: Baseline, up to 39 months
Mean absolute change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline
Percentage of patients achieving the guideline-recommended LDL-C target at any time
Time frame: Up to 39 months
Percentage of patients achieving the guideline-recommended Low-Density Lipoprotein Cholesterol (LDL-C) target at any time will be collected
9 secondary outcomes
Percentage of patients maintaining the guideline-recommended LDL-C target
Time frame: Up to 39 months
Time- adjusted percentage change in LDL-C from baseline
Time frame: Baseline, month 3, month 9, month 15, month 21, month 27, month 33, month 39
Change in LDL-C from baseline stratified on background therapy
Time frame: Baseline, up to 39 months
Percentage of patients remaining on Inclisiran therapy at each injection visit
Time frame: Up to 39 months
Percentage of patients with dose changes, switching, discontinuation
Time frame: Up to 39 months
Number of ASCVD-related events
Time frame: Up to 39 months
Number of possibly related adverse events
Time frame: Up to 39 months
Number of injection site reactions
Time frame: Up to 39 months
Number of patients with changes in Lp(a) levels for Inclisiran-treated patients
Time frame: Up to 39 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease, run by Novartis Pharmaceuticals.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Mean percent change in LDL-C from baseline (time frame: Baseline, up to 39 months). The study lists 3 primary outcomes in all. 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 2 Jun 2026.