Health Condition 1: I229- Subsequent ST elevation (STEMI) myocardial infarction of unspecified site
Conditions
Interventions
Intervention1: Inclisiran: 300 mg given subcutaneously on day 1 and day 90.
Control Intervention1: Placebo: Matching Placebo given subcutaneously on day 1 and day 90.
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients who have had acute coronary syndrome (e.g. heart attack or chest pain) before being admitted to the hospital & have had LDL-C blood levels between 70mg/dL and 125 mg/dL depending on the statin treatment if any.
Exclusion criteria
Exclusion criteria: 1.Participant who is clinically unstable during hospitalization for the qualifying ACS event. 2. Participant who has undergone or is scheduled to undergo CABG for treatment of the qualifying ACS event. 3. Participant with Active liver disease, Secondary hypercholesterolemia, Homozygous familial hypercholesterolemia. 4. Participant with Renal insufficiency,myopathy, on apheresis at Screening visit. 5. Participant with Fasting triglycerides value more than 400 mg/dL. 6. Participant, who based on the Investigators judgement, could reach the LDL-C target value of less than 55 mg/dL after 4 weeks on statin treatment only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What is the change in participants LDL-C levels at Day 150 after receiving inclisiran with standard treatment compared to placebo with standard treatment?Timepoint: Percent change in LDL-C from baseline to Day 150 | — |
Secondary
| Measure | Time frame |
|---|---|
| How many participants achieve LDL C levels below 70 milligrams per deciliter (mg/dL) (acceptable levels for your disease), 55 mg/dL (ideal levels for your disease), or 100 mg/dL (maximum acceptable levels) after receiving inclisiran with standard treatment compared to placebo with standard treatment, 150 days after start of trial treatment?Timepoint: 1. Participants achieving LDL-C less than 70 mg/dL (yes, no) at Day 150 2. Participants achieving LDL-C less than 55 mg/dL (yes, no) at Day 150 3. Participants achieving LDL-C less than 100 mg/dL (yes, no) (among the subset of participants with LDL-C more than or equal to 100 mg/dL at baseline) at Day 150 4. Participants achieving more than or equal to 50 percent reduction from baseline in LDL-C (yes, no) at Day 150;To assess the mean change (averaged over all postbaseline visits), and the change by visit, from baseline in LDL-C for participants receiving inclisiran treatment compared to placebo, on top of SoCTimepoint: 1. Percent change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) 2. Absolute change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) 3. Percent change in LDL-C from baseline to Day 30 and Day 90 4. Absolute change in LDL-C from baseline to Day 30, Day 90 and Day 150;To assess the change of PCSK9 from baseline to Day 150 in participants on inclisiran treatment compared to placebo, on top of SoCTimepoint: Percent change and absolute change in PCSK9 from baseline to Day 30, Day 90 and Day 150;To assess the change in plasma lipoproteins and triglycerides from baseline to Day 150 in participants on inclisiran treatment compared to placebo, on top of SoCTimepoint: Percent change and absolute change from baseline in: apoB, VLDL, non- HDLC, HDL-C, total cholesterol and triglycerides at Day 150;To assess overall safety and tolerability of inclisiranTimepoint: Number and percentage of | — |
Countries
Australia, Canada, China, France, Germany, Hong Kong, Hungary, India, Japan, Poland, Republic of Korea, Spain, Switzerland
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed