Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary… (NCT05118230) | Clinical Trial Compass
CompletedNot Applicable
Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
China61 participantsStarted 2021-12-09
Plain-language summary
This is a multi-center, prospective, comparative and non-interventional cohort study involving two cohorts, one cohort (Inclisiran Cohort) of patients treated with inclisiran in certain special territories in China (eg. Bo'ao Pilot Zone) and the other cohort (SoC Historical Cohort) of patients treated with standard of care (SoC) in routine clinical practice from EMR database.
Who can participate
Age range18 Years – 105 Years
SexALL
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Inclusion criteria
✓. Confirmed diagnosis of primary hypercholesterolemia or mixed dyslipidemia
✓. Age ≥ 18 years at baseline
✓. Initiated treatment with inclisiran according to the decision of both physician and patient
✓. Signed informed consent(s) must be obtained prior to participation in the study
✓. Confirmed diagnosis of primary hypercholesterolemia or mixed dyslipidemia, with which reference to LDL-C \> 70 mg/dL (1.8 mmol/L)
✓. Age ≥ 18 years
✓. Compliance with the standard lipid-lowering therapy, which is defined as a change from prior lipid-lowering therapy to an optimal lipid-lowering regimen, with the date of compliance with standard lipid-lowering therapy after January 1, 2017 as the index date
✓. With available LDL-C test at baseline, which is defined as the closest LDL-C test to the index date within 6 months prior to the index date
Exclusion criteria
✕. Treatment with monoclonal antibodies directed towards PCSK9 within 90 days before first visit (V1)
✕. Severe hepatic impairment (Child-Pugh class C)
✕. Severe renal impairment (eGFR ≤ 30 mL/min), and/or on hemodialysis
✕. Participation in any cardiovascular clinical trial, concurrent or within the last 30 days of the baseline