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

NCT ID: NCT07214857

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-29

Study Completion Date

2024-10-09

Brief Summary

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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

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Conditions

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Cardiovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Secondary Prevention Population

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

No interventions assigned to this group

High-risk Primary Prevention Population

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

No interventions assigned to this group

Diabetes Population

Patients with diabetes who met the diabetes population eligibility criteria.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years of age or older
* Elevated LDL-C despite statin therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CKJX839D1US03

Identifier Type: -

Identifier Source: org_study_id

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