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

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT07214857
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-29
• Primary Completion: 2024-10-09
• Study Completion: 2024-10-09
• Status Verified: 2025-10
• Study First Submitted: 2025-10-06
• Study First Submitted QC: 2025-10-06
• Last Update Submitted: 2025-10-06
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1385

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States