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

NCT06507852 | Completed

• 1 other identifier: CKJX839A1AT01
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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 familial hypercholesterolemia (FH) administered inclisiran in a real-world setting in Austria.

Conditions

Atherosclerotic Cardiovascular Disease; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients who Received Inclisiran Dose 2 and 3 Within Specified Time Intervals

  Time intervals: * Time from Dose 1 to Dose 2: 5 months or less. * Time from Dose 2 to Dose 3: * Less than 6 months. * Between 6 months and 9 months. * Greater than 9 months.

  Up to 26 months

Secondary Outcomes (28)

• Percentage of Patients Taking Different Concomitant Lipid Lowering Therapy (LLT) at Index Date

  Day 1 of Month 6

• Percentage of Patients who Received Inclisiran Doses Within Specified Time Intervals

  Up to 26 months

• Gender

  Baseline

• Race

  Baseline

• Smoking Status

  Baseline

Study Arms (1)

Overall Cohort

Adult patients with ASCVD and hypercholesterolemia, ASCVD-RE with hypercholesterolemia, or FH, who were prescribed inclisiran in a real-world setting as per clinical practice and according to the label in Austria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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).
• year risk of 20% or greater by Framingham risk score.

You may not qualify if:

• None.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 18, 2024
• Study Start: October 3, 2022
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

US (1)