HypercholesterolaemiaPhase 4NCT06501443
LATAM LOWERS LDL-C
A Phase 4 study testing KJX839 in people with Hypercholesterolaemia, run by Novartis Pharmaceuticals at 11 sites in 2 countries.
Trial summary
This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- KJX839
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 11 Feb 2025to 29 Nov 2026
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke.
- Stable patient: Patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization:
- Was not in cardiogenic shock.
- Did not required invasive hemodynamic, inotropic or vasopressor support.
- Participants are required to be eligible for receiving inclisiran in accordance to approved local label.
- Of note, patients who are initiated on statin therapy during the same hospitalization will not be excluded, as we expect a proportion of patients at baseline to not yet be on statin therapy in this real-world study. This will enhance the generalizability and pragmatic aspects of the study. However, because initiation of statin therapy at or near the time of enrollment could impact the primary outcome (if there is imbalance between the arms, or if there is differential stopping of statin therapy between the arms), we will stratify randomization by this factor and will pre-specify analyses in those who have vs. have not been initiated on statin therapy during the same hospitalization.
Who cannot join
- Currently on PCSK9i therapy (within last 3 months)
- Current participation in another clinical study with another study drug
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
11 sites in 2 countries
Brazil10 sites, 9 recruiting
- Recruiting
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30000
- Recruiting
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30110-934
- Withdrawn
Novartis Investigative Site
Blumenau, Santa Catarina, 89010-500
- Recruiting
Novartis Investigative Site
Campina Gde Do Sul, 83430 000
- Recruiting
Novartis Investigative Site
Campo Largo, Paraná, 83606-177
- Recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90560-032
- Recruiting
Novartis Investigative Site
Salvador, Estado de Bahia, 40170-130
- Recruiting
Novartis Investigative Site
Salvador, 40323-010
- Recruiting
Novartis Investigative Site
São José, Santa Catarina, 88103-901
- Recruiting
Novartis Investigative Site
São José, São Paulo, 15015-110
Argentina1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Corrientes, W3400CDS
About this study
Official title: Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C
This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.
Read the detailed description
The primary objective is to evaluate the impact of inclisiran plus usual care on LDL-C lowering versus usual care after acute MI, confirmed ischemic stroke, or urgent coronary revascularization.
The secondary objective is to compare the LDL-C reduction of both arms in target population.
Study completion for an individual participant is defined as when the participant finishes the last visit (day 330) and any assessments associated with that visit.
- Conditions
- Hypercholesterolaemia
- Being tested
- Usual care, KJX839
- Keywords
- PCSK9i, hypercholesterolemia, atherosclerotic cardiovascular disease, LDL-cholesterol, Latin America
- Medical subject headings
- Hypercholesterolemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careDrug
Treatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines
KJX839Drug
Also called Inclisiran
Inclisiran in solution for subcutaneous injection on day 1, day 90, and day 270
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Patients will receive what is the usual care in their respective countries. Usual care includes physical activity, diet modification, pharmacological therapy as: statin therapy (rosuvastatin, atorvastatin, simvastatin, pravastatin, lovastatin, fluvastatin, pitavastatin), ezetimibe, cholestyramine or bempedoic acid. Receives: Drug: Usual care |
| Inclisiran + Usual Care | Experimental | Patients will receive what is usual care in their countries plus inclisiran 284 mg at baseline, 90 days, and 270 days. Receives: Drug: Usual care; Drug: KJX839 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-C from baseline to 330 days
Impact of inclisiran plus usual care on low-density lipoprotein cholesterol (LDL-C) lowering versus usual care after acute myocardial infarction (MI), confirmed ischemic stroke, or urgent coronary revascularization.
The "baseline" level will be measured according to:
- Baseline LDL-C from Standard of Care: If an LDL-C measurement has already been conducted as part of the standard care practices upon the patient's admission (prior to considering enrollment in the study), this measurement is considered the baseline value for the study.
- Baseline LDL-C for Enrolled Patients: In cases where LDL-C was not performed as part of standard care at admission, the baseline LDL-C measurement will be drawn during 'Visit 0' after the patient has provided informed consent.
Measured: Baseline and Day 330
Secondary outcomes (4)
Proportion of patients with >=50% reduction in LDL-C from baseline.
The "baseline" level will be measured according to:
- Baseline LDL-C from Standard of Care: If an LDL-C measurement has already been conducted as part of the standard care practices upon the patient's admission (prior to considering enrollment in the study), this measurement is considered the baseline value for the study.
- Baseline LDL-C for Enrolled Patients: In cases where LDL-C was not performed as part of standard care at admission, the baseline LDL-C measurement will be drawn during 'Visit 0' after the patient has provided informed consent.
Measured: Baseline and Day 330
Proportion of patients achieving LDL-C goal of <70 mg/dL
Reducing LDL-C to a threshold of at least 70 mg/dL is a cornerstone of secondary prevention therapy, and is recommended by major international guidelines.
Measured: Baseline and Day 330
Among participants with a baseline LDL-C≥55 mg/dL: Proportion of patients achieving LDL-C goal of <55 mg/dL
The "baseline" level will be measured according to:
- Baseline LDL-C from Standard of Care: If an LDL-C measurement has already been conducted as part of the standard care practices upon the patient's admission (prior to considering enrollment in the study), this measurement is considered the baseline value for the study.
- Baseline LDL-C for Enrolled Patients: In cases where LDL-C was not performed as part of standard care at admission, the baseline LDL-C measurement will be drawn during 'Visit 0' after the patient has provided informed consent.
Measured: Baseline and Day 330
Number of participants by timing of statin initiation
Number of participants by statin initiated during index hospitalization vs. not.
Measured: Up to 330 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start11 Feb 2025
- Primary completion27 Nov 2026 (estimated)
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 520 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
- NCT06501443
- Sponsor's protocol ID
- CKJX839A1MX02
- Status last verified
- Dec 2025
- First submitted
- 21 Jun 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C
- ClinicalTrials.gov ID
- NCT06501443
- Acronym / sponsor ID
- CKJX839A1MX02
- Conditions
- Hypercholesterolaemia
- Keywords
- PCSK9i, hypercholesterolemia, atherosclerotic cardiovascular disease, LDL-cholesterol, Latin America
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 27 Nov 2026 (estimated)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 15 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 is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.
Detailed description
The primary objective is to evaluate the impact of inclisiran plus usual care on LDL-C lowering versus usual care after acute MI, confirmed ischemic stroke, or urgent coronary revascularization.
The secondary objective is to compare the LDL-C reduction of both arms in target population.
Study completion for an individual participant is defined as when the participant finishes the last visit (day 330) and any assessments associated with that visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Drug: Usual carePatients will receive what is the usual care in their respective countries. Usual care includes physical activity, diet modification, pharmacological therapy as: statin therapy (rosuvastatin, atorvastatin, simvastatin, pravastatin, lovastatin, fluvastatin, pitavastatin), ezetimibe, cholestyramine or bempedoic acid. |
| Inclisiran + Usual Care | Experimental | Drug: Usual care, Drug: KJX839Patients will receive what is usual care in their countries plus inclisiran 284 mg at baseline, 90 days, and 270 days. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke.
- Stable patient: Patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization:
- Participants are required to be eligible for receiving inclisiran in accordance to approved local label.
Key exclusion criteria (5 listed)
- Currently on PCSK9i therapy (within last 3 months)
- Current participation in another clinical study with another study drug
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
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 |
|---|---|---|
| Usual careTreatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines | Drug | Inclisiran + Usual Care, Usual Care |
| KJX839Also: InclisiranInclisiran in solution for subcutaneous injection on day 1, day 90, and day 270 | Drug | Inclisiran + Usual Care |
Primary outcome
Change in LDL-C from baseline to 330 days
Time frame: Baseline and Day 330
Impact of inclisiran plus usual care on low-density lipoprotein cholesterol (LDL-C) lowering versus usual care after acute myocardial infarction (MI), confirmed ischemic stroke, or urgent coronary revascularization. The "baseline" level will be measured according to: * Baseline LDL-C from Standard of Care: If an LDL-C measurement has already been conducted as part of the standard care practices upon the patient's admission (prior to considering enrollment in the study), this measurement is considered the baseline value for the study. * Baseline LDL-C for Enrolled Patients: In cases where LDL-C was not performed as part of standard care at admission, the baseline LDL-C measurement will be drawn during 'Visit 0' after the patient has provided informed consent.
4 secondary outcomes
Proportion of patients with >=50% reduction in LDL-C from baseline.
Time frame: Baseline and Day 330
Proportion of patients achieving LDL-C goal of <70 mg/dL
Time frame: Baseline and Day 330
Among participants with a baseline LDL-C≥55 mg/dL: Proportion of patients achieving LDL-C goal of <55 mg/dL
Time frame: Baseline and Day 330
Number of participants by timing of statin initiation
Time frame: Up to 330 days
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 30 Dec 2025.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KJX839 in people with Hypercholesterolaemia, run by Novartis Pharmaceuticals at 11 sites in 2 countries.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil, Argentina. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL-C from baseline to 330 days (time frame: Baseline and 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 30 Dec 2025.