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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
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521670-34-00
Enrollment
24
Registered
2026-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute coronary syndrome (ST-elevation myocardial infarction [STEMI] or non-ST-elevation myocardial infarction [NSTEMI]) of recent onset.

Brief summary

Percent change in LDL-C from baseline to Day 150

Detailed description

• Participants achieving LDL-C <70 mg/dL (yes, no) at Day 150 • Participants achieving LDL-C <55 mg/dL (yes, no) at Day 150 • Participants achieving LDL-C <100 mg/dL (yes, no) (among the subset of participants with LDL-C ≥100 mg/dL at baseline) at Day 150 • Participants achieving ≥50% reduction from baseline in LDL-C (yes, no) at Day 150, • Percent change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) • Absolute change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) • Percent change in LDL-C from baseline to Day 30 and Day 90 • Absolute change in LDL-C from baseline to Day 30, Day 90 and Day 150, Percent change and absolute change in PCSK9 from baseline to Day 30, Day 90 and Day 150, Percent change and absolute change from baseline in: apoB, VLDL, non-HDLC, HDL-C, total cholesterol and triglycerides at Day 150, Number and percentage of participants experiencing treatment emergent AEs or SAEs

Interventions

DRUGROSUVASTATIN
DRUGATORVASTATIN
DRUGINCLISIRAN
DRUGPlacebo to KJX839 (Inclisiran)

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent change in LDL-C from baseline to Day 150

Secondary

MeasureTime frame
• Participants achieving LDL-C <70 mg/dL (yes, no) at Day 150 • Participants achieving LDL-C <55 mg/dL (yes, no) at Day 150 • Participants achieving LDL-C <100 mg/dL (yes, no) (among the subset of participants with LDL-C ≥100 mg/dL at baseline) at Day 150 • Participants achieving ≥50% reduction from baseline in LDL-C (yes, no) at Day 150, • Percent change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) • Absolute change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) • Percent change in LDL-C from baseline to Day 30 and Day 90 • Absolute change in LDL-C from baseline to Day 30, Day 90 and Day 150, Percent change and absolute change in PCSK9 from baseline to Day 30, Day 90 and Day 150, Percent change and absolute change from baseline in: apoB, VLDL, non-HDLC, HDL-C, total cholesterol and triglycerides at Day 150, Number and percentage of participants experiencing treat

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 17, 2026