An observational study in Atherosclerotic Cardiovascular Disease and Hypercholesterolemia, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Novartis · Observational
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 95 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
This was a retrospective, noninterventional cohort study.
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:
Exclusion Criteria:
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.
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.
Time frame: Up to 26 months
Percentage of Patients Taking Different Concomitant Lipid Lowering Therapy (LLT) at Index Date
Index date was defined as the date of first administration of inclisiran.
Time frame: Day 1 of Month 6
Percentage of Patients who Received Inclisiran Doses Within Specified Time Intervals
Time intervals: * Time from Dose 1 to Dose 2: * Less than 3.5 months. * Between 3.5 and 5 months. * Greater than 5 months. * Time from Dose 2 to Dose 3: * Less than 6 months. * Between 6 and 7 months. * Between 7 and 8 months. * Between 8 and 9 months. * Greater than 9 months.
Time frame: Up to 26 months
Gender
Time frame: Baseline
Race
Time frame: Baseline
Smoking Status
Patient smoker status: * Non-smoker * Current smoker * Past smoker * Unknown
Time frame: Baseline
Physical Activity
Physical activity was classified as intense, light, moderate, or unknown.
Time frame: Baseline
Prescribing Physician Specialty
Time frame: Baseline
Age
Time frame: Baseline
Weight
Time frame: Baseline
Height
Time frame: Baseline
Body Mass Index
Time frame: Baseline
Blood Pressure
Blood pressure: systolic and diastolic.
Time frame: Baseline
Percentage of Male Patients by Age Group
Age groups: * Less than 15 years old. * 15 to 19 years old. * 20 to 29 years old. * 30 to 39 years old. * 40 to 49 years old. * 50 to 59 years old. * 60 years or older.
Time frame: Baseline
Percentage of Female Patients by Age Group
Age groups: * Less than 15 years old. * 15 to 19 years old. * 20 to 29 years old. * 30 to 39 years old. * 40 to 49 years old. * 50 to 59 years old. * 60 years or older.
Time frame: Baseline
Percentage of Patients Categorized by Comorbidities
Time frame: Baseline
Cholesterol
Cholesterol included: * Low-density lipoprotein cholesterol. * High-density lipoprotein cholesterol. * Non-high-density lipoprotein cholesterol. * Total cholesterol.
Time frame: Baseline
Triglycerides
Time frame: Baseline
Apolipoprotein B
Time frame: Baseline
Glycated hemoglobin
Time frame: Baseline
Lipoprotein(a)
Time frame: Baseline
Creatinine
Time frame: Baseline
Alanine Aminotransferase
Time frame: Baseline
Aspartate Aminotransferase
Time frame: Baseline
Alkaline phosphatase
Time frame: Baseline
Percentage of Patients With Procedures
Time frame: Baseline
Percentage of Atherosclerotic Cardiovascular Disease (ASCVD) Patients Categorized by Qualifying Diagnosis
Qualifying diagnoses were coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease (CVD).
Time frame: Baseline
Percentage of ASCVD-risk Equivalent Patients Categorized by Qualifying Criteria
Qualifying Criteria: * Type II diabetes mellitus. * Framingham risk score of 20% or greater. * Type I diabetes mellitus of for more than 20 years.
Time frame: Baseline
Percentage of Patients Categorized by Lipid Lowering Therapies (LLTs) Prior to Index Date
Index date was defined as the date of first administration of inclisiran.
Time frame: Up to 6 months pre-index date
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis