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siRNA

Inclisiran for Acute Coronary Syndrome (V-INCEPTION Trial)

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Calculated glomerular filtration rate >20 mL/min by estimated glomerular filtration rate (eGFR)
Calculated glomerular filtration rate >20 mL/min by estimated glomerular filtration rate (eGFR)
Must not have
New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction <25%.
Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after day 90 up to day 330
Awards & highlights

Summary

This trial will study whether inclisiran, a new cholesterol-lowering drug, is effective in reducing LDL-cholesterol in patients who have recently experienced an ACS and are already taking a statin drug.

Who is the study for?
This trial is for adults who've had a recent heart-related emergency (Acute Coronary Syndrome) and have high bad cholesterol levels despite taking statins. They should not be on other experimental treatments, have severe heart failure or life-threatening diseases, or plan to undergo heart procedures soon.
What is being tested?
The study tests if adding Inclisiran to usual care lowers bad cholesterol more effectively than usual care alone in patients with recent Acute Coronary Syndrome. It aims to establish a systematic LDL-cholesterol management pathway.
What are the potential side effects?
Inclisiran may cause side effects like injection site reactions, allergic responses, common cold symptoms, and potential liver enzyme elevations. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by eGFR, is above 20 mL/min.
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My kidney function, measured by eGFR, is above 20 mL/min.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's pumping ability is severely reduced.
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I have had serious heart rhythm problems in the last 3 months that are not controlled by medication or procedures.
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I have a serious illness besides heart disease that may shorten my life to under 2 years.
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I haven't used any experimental drugs or devices in the last 30 days or longer.
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I had a heart problem again less than 2 weeks ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after day 90 up to day 330
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after day 90 up to day 330 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Weight Changes
Percentage (%) change in low-density lipoprotein cholesterol (LDL-C)
Secondary study objectives
Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C)
Absolute change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol
Achieving ≥ 50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) (yes, no)
+6 more

Side effects data

From 2019 Phase 3 trial • 482 Patients • NCT03397121
12%
Nasopharyngitis
9%
Injection site reaction
7%
Upper respiratory tract infection
7%
Back pain
5%
Influenza
1%
Acute myocardial infarction
1%
Aortic valve stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Inclisiran

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Inclisiran with Usual CareExperimental Treatment1 Intervention
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Group II: Usual CareActive Control1 Intervention
Usual Care Alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
2021
Completed Phase 3
~2650

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,620 Total Patients Enrolled

Media Library

Inclisiran (siRNA) Clinical Trial Eligibility Overview. Trial Name: NCT04873934 — Phase 3
Acute Coronary Syndrome Research Study Groups: Inclisiran with Usual Care, Usual Care
Acute Coronary Syndrome Clinical Trial 2023: Inclisiran Highlights & Side Effects. Trial Name: NCT04873934 — Phase 3
Inclisiran (siRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04873934 — Phase 3
~92 spots leftby Sep 2025
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