Inclisiran for Atherosclerotic Cardiovascular Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Atherosclerotic Cardiovascular DiseaseInclisiran - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cholesterol-lowering injection to see if it safely lowers the risk of heart attacks and strokes.

Eligible Conditions
  • Atherosclerotic Cardiovascular Disease

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Median follow-up of 5-years

Median follow-up of 5-years
Number of participants with MACE among those recorded to be taking high-intensity statin at baseline
Number of participants with a composite of CHD death or myocardial infarction
Number of participants with a major adverse cardiovascular event (MACE)
Number of participants with cardiovascular death

Trial Safety

Safety Progress

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

Side Effects for

Inclisiran
12%Nasopharyngitis
9%Injection site reaction
7%Back pain
7%Upper respiratory tract infection
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%, Back pain with 7%, Upper respiratory tract infection with 7%, Influenza with 5%.

Trial Design

2 Treatment Groups

Inclisiran
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

15000 Total Participants · 2 Treatment Groups

Primary Treatment: Inclisiran · Has Placebo Group · Phase 3

Inclisiran
Drug
Experimental Group · 1 Intervention: Inclisiran · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
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: median follow-up of 5-years

Who is running the clinical trial?

University of OxfordLead Sponsor
965 Previous Clinical Trials
16,200,864 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,718 Previous Clinical Trials
3,510,387 Total Patients Enrolled
The TIMI Study GroupOTHER
12 Previous Clinical Trials
67,311 Total Patients Enrolled
Martin LandrayPrincipal InvestigatorUniversity of Oxford
2 Previous Clinical Trials
56,122 Total Patients Enrolled
Louise BowmanPrincipal InvestigatorUniversity of Oxford
1 Previous Clinical Trials
30,449 Total Patients Enrolled
Marion MafhamPrincipal InvestigatorUniversity of Oxford
1 Previous Clinical Trials
20,000 Total Patients Enrolled
David PreissPrincipal InvestigatorUniversity of Oxford
1 Previous Clinical Trials
20,000 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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