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Recruiting NCT07102628

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

Conditions: Acute Coronary Syndrome

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 300
Sponsor: Novartis Pharmaceuticals

Location: Novartis Investigative Site Clayton Victoria

Summary

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

Inclusion Criteria: Participant eligible for inclusion in this study must meet all the following criteria: At Screening: 1. Signed informed consent must be obtained prior to participation in the study. 2. Males and females, ≥18 years of age at the time of providing written informed consent. 3. Ability to understand study's requirements and provide informed consent and comply with all required study procedures. 4. Hospitalization for a ACS event (STEMI or NSTEMI). 5. Receiving treatment for the qualifying ACS event, according to clinical judgement, by means of medical treatment alone or percutaneous coronary revascularization. 6. Had a successful PCI (with or without stent) for the qualifying event if a PCI was required. 7. LDL-C value at the Screening visit measured by the local lab of: * LDL-C ≥70 mg/dL in participant previously treated with high-intensity statin (atorvastatin ≥40 mg/day or rosuvastatin ≥20 mg/day) or equivalent as per national guidelines and local regulation for at least 4 weeks before screening or * LDL-C ≥100 mg/dL in participant previously treated with low/moderate-intensity statin for at least 4 weeks before screening or * LDL-C ≥125 mg/dL in participant previously not treated with statins for at least 4 weeks before screening, or who never received statins (including statin intolerant participants). At Randomization: 8. The participant must have a Baseline fasting LDL-C ≥70 mg/dL (local lab assessment) to be eligible for randomization. 9. Randomization within 7 days (≤ 7 days) following hospital admission for the qualifying ACS event and before/at discharge. Exclusion Criteria: Participant meeting any of the following criteria is not eligible for inclusion in this study. Only for Japan: For exclusion criteria 6, investigator judgment should be documented in the source data document. 1. Participant who is clinically unstable during hospitalization for the qualifying ACS event, defined by any of the following events within 24 hours prior to randomization: * Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of \110 mmHg prior to randomization despite antihypertensive therapy. 2. Participant who has undergone or is scheduled to undergo CABG for treatment of the qualifying ACS event. 3. Active liver disease defined as: (i) any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) alanine aminotransferase (ALT) elevation \>3x ULN or aspartate aminotransferase (AST) elevation \>3x ULN, or total bilirubin elevation \>2x ULN (except participant with Gilbert's syndrome) at the Screening visit, in the context of an ACS, and assessed as related to the index event and/or treatment procedures (such as PCI). Eligibility will be based on Investigator's judgement for participant who will be randomized. 4. Renal insufficiency (eGFR \400 mg/dL (4.52 mmol/L; assessed by local labs) at randomization visit. 6. Participant, who based on the Investigator's judgement, could reach the LDL-C target value of \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07102628). StuddyBuddy aggregates publicly available trial information.