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Anti-metabolites
Inclisiran for Cardiovascular Disease (V-INCLUSION Trial)
Phase 4
Recruiting
Led By Neha Pagidipati, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
2. Have clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR
3. Serum LDL-C ≥ 70 mg/dL for participants with ASCVD, or LDL-C ≥ 100 mg/dL for ASCVD risk equivalent participants, based on last recorded LDL-C value within the preceding eighteen (18) months without a subsequent change in lipid lowering therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90, day 270, day 360
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial aims to study how well inclisiran works as a new treatment for people at high risk of or already diagnosed with a certain heart condition. It will use electronic health records from different healthcare systems
Who is the study for?
The VictORION-INCLUSION trial is for adults over 18 with cardiovascular disease or at high risk, as noted in their health records. Participants must have LDL cholesterol above certain levels despite being on statins or having a documented intolerance to them. The study focuses on including underrepresented groups such as women, ethnic minorities, and rural residents.
What is being tested?
This trial tests Inclisiran's ability to manage cholesterol in heart disease patients. It uses electronic health records from US Healthcare Systems to quickly identify and treat those at high risk or with diagnosed atherosclerotic cardiovascular disease (ASCVD) to lower LDL-C levels faster.
What are the potential side effects?
While the specific side effects of Inclisiran are not listed here, similar medications often cause injection site reactions, muscle pain, allergic reactions, liver enzyme changes, and flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a diagnosis of heart disease or a condition with similar risk.
Select...
My last LDL cholesterol level was high and I haven't changed my cholesterol medication since then.
Select...
I belong to a group often underrepresented in heart disease studies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 90, day 270, day 360
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90, day 270, day 360
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Achievement of LDL-C targets
Secondary study objectives
Absolute change from baseline in LDL-C
Average absolute change from baseline in LDL-C at each post-baseline visit
Average percent change from baseline in LDL-C at each post-baseline visit
+2 moreOther study objectives
Change in Medication Adherence Report Scale
Change in Treatment Satisfaction Questionnaire for Medication Score
Side effects data
From 2019 Phase 3 trial • 482 Patients • NCT0339712112%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InclisiranExperimental Treatment1 Intervention
Inclisiran + Usual Care
Group II: Usual CareActive Control1 Intervention
Usual Care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
2021
Completed Phase 3
~3430
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsIndustry Sponsor
2,919 Previous Clinical Trials
4,253,067 Total Patients Enrolled
Duke UniversityLead Sponsor
2,462 Previous Clinical Trials
2,967,480 Total Patients Enrolled
Neha Pagidipati, MDPrincipal InvestigatorDuke Clinical Research Institute