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Early in-hospital start of inclisiran for people with acute coronary syndrome

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes: Victorion - RIDES

Phase 3 Interventional Novartis · NCT07102628

This study tests whether giving inclisiran soon after hospital admission helps people with acute coronary syndrome when added to standard care compared with a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorNovartis Industry-sponsored
Locations58 sites (Clayton, Victoria and 57 other locations)
Trial IDNCT07102628 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial with two parallel arms comparing inclisiran to placebo in patients hospitalized with recent-onset acute coronary syndrome (STEMI or NSTEMI). Study drug is started at randomization during the in-hospital phase within 7 days of admission and before discharge, and participants are followed through a 150-day double-blind treatment period with scheduled safety calls and a 30-day safety follow-up after the end of treatment. Eligible patients must be adults hospitalized for ACS, able to consent, and have LDL-C ≥70 mg/dL while on high-intensity statin therapy or equivalent per local guidelines. The trial will be conducted at selected Novartis investigative sites in Australia, Canada, and China.

Who should consider this trial

Good fit: Adults (≥18) hospitalized for STEMI or NSTEMI within 7 days of admission who can consent, are on or eligible for high-intensity statin therapy, and have LDL-C ≥70 mg/dL are the intended participants.

Not a fit: People with LDL-C below the study threshold on high-intensity statins, those not hospitalized for ACS, or patients with contraindications to inclisiran are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, early in-hospital inclisiran could lower LDL cholesterol quickly and may reduce the risk of recurrent cardiac events after an acute coronary syndrome.

How similar studies have performed: Prior phase 3 trials of inclisiran have shown durable and substantial LDL-C lowering, but outcome benefits specifically when started early after ACS are not yet established.

Eligibility criteria

Show full inclusion / exclusion 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 \<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
   * Left ventricular ejection fraction \<20% at randomization (after all treatment procedures, based on the latest assessment of the LVEF using invasive or non-invasive assessment modalities)
   * Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>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 \<30 mL/min/1.73m2) at the Screening visit.
5. Fasting triglycerides value \>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 \<55 mg/dL after 4 weeks on statin treatment only.
7. Secondary hypercholesterolemia (based on medical history).
8. Homozygous familial hypercholesterolemia (based on medical history).
9. Participant on apheresis at the Screening visit.
10. Ongoing or medical history of myopathy at the Screening visit.
11. CK values ≥5x ULN at Screening visit and confirmed by repeat test during Screening (local lab) , 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 (who will be switched to or initiated on the protocol-specified dose of high-intensity statin of atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD). Unless a more stringent CK value threshold is mandated by a local regulatory authority (e.g., ≥3x ULN in Korea according to MFDS internal guideline).

Where this trial is running

Clayton, Victoria and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Coronary SyndromeKJX839ACSNSTEMISTEMIInclisiranLDL-CHyperlipidemia
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.