Evaluating the impact of inclisiran on lowering LDL cholesterol in patients after acute cardiovascular events

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized clinical trial aims to assess the effectiveness of inclisiran combined with usual care compared to usual care alone in reducing LDL cholesterol levels in patients who have experienced acute myocardial infarction, ischemic stroke, or urgent coronary revascularization. The study will involve multiple countries in Latin America and will focus on patient-reported outcomes and healthcare resource utilization. Participants will be monitored for 330 days post-enrollment to evaluate the long-term effects of the treatment.

Why it matters

Who can join: the full rules

Inclusion 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. 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:

* 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

Where it's running

• Novartis Investigative Site
  Corrientes, Argentina Recruiting
• Novartis Investigative Site
  Salvador, Estado de Bahia, Brazil Recruiting
• Novartis Investigative Site
  Belo Horizonte, Minas Gerais, Brazil Recruiting
• Novartis Investigative Site
  Belo Horizonte, Minas Gerais, Brazil Recruiting
• Novartis Investigative Site
  Campo Largo, Paraná, Brazil Recruiting
• Novartis Investigative Site
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.