Status:
COMPLETED
A Real-world Study of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness in ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia
Lead Sponsor:
Novartis
Conditions:
Atherosclerotic Cardiovascular Disease
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Brief Summary
This was a descriptive, non-interventional, retrospective cohort study among patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent (ASCVD-RE) or ...
Eligibility Criteria
Inclusion
- Patients who were 18 years or older.
- Signed informed consent was obtained.
- Patients who received at least one inclisiran injection in the identification period.
- Patients with at least one diagnosis of ASCVD, ASCVD-RE or FH diagnosis prior to index date.
- Patients with at least one low-density lipoprotein cholesterol (LDL-C) measurement of 70 milligrams per deciliter (mg/dL) or greater, within 6 months prior to index date.
- ASCVD was defined as previous diagnosis of coronary artery disease (CAD), peripheral artery disease (PAD) or cerebrovascular disease (CVD).
- ASCVD-RE was defined as: no previous diagnosis of ASCVD at any time on the patient chart and they met at least one of the following criteria:
- Diagnosis of type II diabetes mellitus (T2DM).
- Diagnosis of type I diabetes mellitus (T1DM) of long duration (greater than 20 years).
- 10-year risk of 20% or greater by Framingham risk score.
Exclusion
- • None.
Key Trial Info
Start Date :
October 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 6 2023
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT06507852
Start Date
October 3 2022
End Date
July 6 2023
Last Update
July 18 2024
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936