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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)
Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after day 90 up to day 330
Awards & highlights

V-INCEPTION Trial 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.Check my eligibility
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.See study design
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.

V-INCEPTION 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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I had a heart attack or severe chest pain within the last 5 weeks.
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My kidney function, measured by eGFR, is above 20 mL/min.
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I am on statin therapy or cannot take it due to severe side effects.

V-INCEPTION Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Percentage (%) change in low-density lipoprotein cholesterol (LDL-C)
Secondary outcome measures
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

V-INCEPTION 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
~2240

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,852 Previous Clinical Trials
4,197,361 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose is Inclisiran primarily being prescribed?

"Inclisiran is commonly used to treat primary hypercholesterolemia. However, it can also be employed to help manage diet and atherosclerotic cardiovascular diseases."

Answered by AI

What are some other instances where Inclisiran has been studied?

"The first clinical trials for inclisiran occurred in 2018 at the TIMI Study Group. Presently, there are 11 completed studies and 11 active ones. Out of all the locations where these studies take place, a significant number occur in Pittsburgh, Pennsylvania."

Answered by AI

How does Inclisiran's safety profile compare to other drugs?

"Inclisiran has received a score of 3 for safety from our team at Power. This is because there is some efficacy data as well as multiple rounds of supportive safety data, meaning that it is a Phase 3 trial."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
~51 spots leftby Aug 2024