Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals

About this trial

The purpose of this trial is to learn about the effects of inclisiran in people with serious heart conditions (acute coronary syndromes), when this treatment is started early after hospital admission. To do this, researchers will test the effects of inclisiran compared to placebo, when given with standard treatment.

Eligibility criteria

Qualifiers

Signed informed consent must be obtained prior to participation in the study.

Males and females, ≥18 years of age at the time of providing written informed consent.

Ability to understand study's requirements and provide informed consent and comply with all required study procedures.

Hospitalization for a ACS event (STEMI or NSTEMI).

Disqualifiers

Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of <90 mmHg due to cardiac failure with associated symptoms requiring inotropes

Arrhythmic events: Ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter)

Cardiogenic shock or mechanical complication of myocardial infarction

New York Heart Association (NYHA) class IV heart failure

Trial design

Treatments tested in this trial

  • Placebo
  • Inclisiran

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators