Inclisiran for Acute Coronary Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Acute Coronary Syndrome+1 More
Inclisiran - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Acute Coronary Syndrome

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Baseline, after Day 90 up to Day 330

Baseline and Day 330
Absolute change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol
Measurement of the intensity of lipid lowering therapy (dose decrease, increase or no change)
Percent change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol
Body Weight Changes
Percentage (%) change in low-density lipoprotein cholesterol (LDL-C)
Percentage of participants discontinuing statin therapy (i.e., no statin use ≥ 30 days before the end-of-study visit)
Baseline to Day 330
Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C)
Day 330
Achieving ≥ 50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) (yes, no)
Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit
Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit
Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) targets (LDL-C < 100 mg/dL among the subset of participants with LDL-C ≥ 100 mg/dL at baseline, and LDL-C < 55 mg/dL)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

Side Effects for

Inclisiran
12%Nasopharyngitis
9%Injection site reaction
7%Upper respiratory tract infection
7%Back pain
5%Influenza
1%Aortic valve stenosis
1%Acute myocardial infarction
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT03397121) in the Inclisiran ARM group. Side effects include: Nasopharyngitis with 12%, Injection site reaction with 9%, Upper respiratory tract infection with 7%, Back pain with 7%, Influenza with 5%.

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Inclisiran with Usual Care
1 of 2

Active Control

Experimental Treatment

384 Total Participants · 2 Treatment Groups

Primary Treatment: Inclisiran · No Placebo Group · Phase 3

Inclisiran with Usual Care
Drug
Experimental Group · 1 Intervention: Inclisiran · Intervention Types: Drug
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, after day 90 up to day 330

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,697 Previous Clinical Trials
3,523,757 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS.
You have had a recent acute coronary syndrome (in-patient/out-patient) within 5 weeks of screening.
You have high LDL-C or non-HDL-C levels.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: November 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.