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New treatment option for Hypercholesterolaemia
Official title LATAM LOWERS LDL-C
ClinicalTrials.gov ID: NCT06501443
What this study is testing
What is KJX839?
KJX839 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hypercholesterolaemia.
Also referred to as Inclisiran.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Corrientes, Argentina
- Salvador, Estado de Bahia, Brazil
- Belo Horizonte, Minas Gerais, Brazil
- Campo Largo, Paraná, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Blumenau, Santa Catarina, Brazil
- São José, Santa Catarina, Brazil
- São José, São Paulo, Brazil
- Campina Gde Do Sul, Brazil
- Salvador, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Corrientes, Argentina; Salvador, Estado de Bahia, Brazil; Belo Horizonte, Minas Gerais, Brazil; Campo Largo, Paraná, Brazil; Porto Alegre, Rio Grande do Sul, Brazil; Blumenau, Santa Catarina, Brazil and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.