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In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease

NCT05974345 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 204691

Last updated 2024-05-08

No results posted yet for this study

Summary

Study CKJX839B1FR01 in an In silico trial to predict the efficacy of Inclisiran therapy on major adverse cardiovascular events (MACE) and cardiovascular (CV) death in virtual patients with atherosclerotic cardiovascular disease (ASCVD) and elevated LDL-C.

Conditions

Interventions

DRUG

Inclisiran sodium

Drug: Inclisiran sodium 300 mg virtually subcutaneously administered on Day 1, Month 3 (Day 90) and every 6 months thereafter until end of simulation.

DRUG

Placebo

Drug: Placebo virtually subcutaneously administered on Day 1, Month 3 (Day 90) and every 6 months thereafter until end of simulation.

DRUG

Ezetimibe

Drug: Ezetimibe 10 mg virtually orally once a day until end of simulation.

DRUG

Evolocumab

Drug: Evolocumab 140 mg virtually subcutaneously administered every two weeks until end of simulation.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-03
Primary Completion
2023-12-15
Completion
2023-12-15

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05974345 on ClinicalTrials.gov