Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Novartis Health Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age greater than equal to 18 years 2. PCI/CABG procedure performed between Jan 1, 2024 and June 30, 2025 3. Test group: Received 1st dose of Inclisiran within plus minus 5 days of the PCI/CABG procedure / Control group: Received standard lipid lowering therapies within plus minus 5 days of the PCI/CABG procedure. 4. Availability of LDL-C value estimated within plus minus 5 days of PCI/CABG procedure 5. Availability of LDL-C value estimated within 90 plus minus 5 days of PCI/CABG procedure 6. LDL-C level greater than equal 70 mg/dl.
Exclusion criteria
Exclusion criteria: 1. Documented homozygous familial hypercholesterolemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage change in LDL-C value from baseline to 90-days 5 days post PCI and/or CABG.Timepoint: 0 and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographics: Descriptive analysis of age, sex and body mass index (BMI).Timepoint: 0 month;Co-morbidities: Descriptive analysis of hypertension, diabetes mellitus, and other significant co-morbidities in the context of dyslipidemia and ASCVD.Timepoint: 0 month;Baseline analysis of: Type of MI (if available),LV Ejection Fraction prior to PCI/CABG, Number of culprit lesions and Number of stents (if applicable)Timepoint: 0 month;Descriptive analysis of baseline and change (when available) in the values of LDLC, HDLC, triglycerides, ApoB and Lp(a), hsCRP and HbA1c.Timepoint: 0 and 3 months;Absolute change in LDL-C value from baseline to 90 5 days post PCI and/or CABGTimepoint: 0 and 3 months;Descriptive analysis of type and dose of lipid-lowering therapy and LDL-C target attainment, change in therapy and dosage of data if available will also be analysed.Timepoint: 0 and 3 months;Proportion of patients with LDL-C values within target goal at 90 days 5 days (less than 55 mg/dl)Timepoint: 0 and 3 months;Descriptive analysis of adverse events and hospitalizations if any after initiation of lipid lowering therapy.Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Manish Bansal
Heart Institute, Medanta-The Medicity
Outcome results
None listed