Potential Eligibility and Estimated Preventable Cardiovascular Disease Events From Inclisiran Treatment in the United States

NCT07214857 | Completed

• 1 other identifier: CKJX839D1US03
• Study Type: observational
• Target: 1,385
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to estimate the number of United States (US) adults with and without prior atherosclerotic cardiovascular disease (ASCVD) and diabetes who may be eligible for inclisiran based on US National Health and Nutrition Examination Survey (NHANES) data and inclisiran eligibility criteria from ongoing clinical trials as well as to estimate the number of preventable ASCVD events based on expected risk reductions from the degree of low-density lipoprotein cholesterol (LDL-C) lowering expected from inclisiran. This study used data from the US NHANES 2011-2020 surveys. NHANES is a national survey which collects medical history, laboratory, and medication information from participants of all ages.

Conditions

Cardiovascular Disease

Keywords

Prevention; Inclisiran; Statins; Diabetes

Outcome Measures

Primary Outcomes (2)

• Estimated Number of US Patients Eligible for Inclisiran Treatment

  10 years

• Estimated Number of Preventable Cardiovascular Events Over 10-years of Inclisiran Treatment

  10 years

Study Arms (3)

Secondary Prevention Population

Patients with known ASCVD who met the secondary prevention population eligibility criteria.

High-risk Primary Prevention Population

Patients without known ASCVD who met the high-risk primary prevention population eligibility criteria.

Diabetes Population

Patients with diabetes who met the diabetes population eligibility criteria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This was a cross-sectional, non-interventional cohort study.

You may qualify if:

• Aged 18 years of age or older
• Elevated LDL-C despite statin therapy

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 9, 2025
• Study Start: March 29, 2024
• Primary Completion: October 9, 2024
• Study Completion: October 9, 2024
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)