Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
520 participants
INTERVENTIONAL
2025-02-11
2026-11-29
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Usual Care
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.
Usual care
Treatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines
Inclisiran + Usual Care
Patients will receive what is usual care in their countries plus inclisiran 284 mg at baseline, 90 days, and 270 days.
Usual care
Treatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines
KJX839
Inclisiran in solution for subcutaneous injection on day 1, day 90, and day 270
Interventions
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Usual care
Treatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines
KJX839
Inclisiran in solution for subcutaneous injection on day 1, day 90, and day 270
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Corrientes, , Argentina
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Campo Largo, Paraná, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Blumenau, Santa Catarina, Brazil
Novartis Investigative Site
São José, Santa Catarina, Brazil
Novartis Investigative Site
São José, São Paulo, Brazil
Novartis Investigative Site
Campina Gde Do Sul, , Brazil
Novartis Investigative Site
Salvador, , Brazil
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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CKJX839A1MX02
Identifier Type: -
Identifier Source: org_study_id