NCT07102628

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, prospective, randomized, double-blind, placebo-controlled, two arms, parallel groups clinical trial in participants experiencing an ACS (STEMI or NSTEMI) of recent onset. The study drug treatment (inclisiran/placebo) will be initiated at randomization (Day 1) and before discharge. The study consists of: 1. Screening visit within 7 days (≤ 7 days) from hospital admission. Screening visit might happen at hospital admission day or any time after hospital admission and before randomization (Day 1). 2. Randomization/Baseline visit (Day 1) within 7 days (≤ 7 days) from hospital admission and before or at day of discharge. The discharge can happen any time after randomization and first study drug administration (Day 1). 3. Double-blinded treatment period (150 days). 4. Scheduled safety calls in between visits during the double-blind treatment period (they do not replace on-site visits) 5. Safety Follow-up call (30 days after EOS visit) Screening and randomization visits must happen during the in-hospital phase, within 7 days (≤ 7 days), and before discharge. The Screening period, of no more than 6 days after the date of hospital admission, will be used to determine if patients qualify to enter the double-blind treatment phase of the study. Screening and Randomization/Day 1 visits cannot occur on the same day. The overall study duration is 150 days.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Placebo	The participants will receive placebo subcutaneous at randomization (Day 1, Baseline visit) and Day 90
DRUG	Inclisiran	The participants will receive Inclisiran sodium 300 mg subcutaneous at randomization (Day 1, Baseline visit) and Day 90

Timeline

• Start date: 2025-10-03
• Primary completion: 2027-02-15
• Completion: 2027-02-15
• First posted: 2025-08-04
• Last updated: 2026-04-01

Locations

52 sites across 13 countries: Australia, Canada, China, France, Germany, Hong Kong, Hungary, India, Japan, Poland, South Korea, Spain, Switzerland