Acute coronary syndrome (ST-elevation myocardial infarction [STEMI] or non-ST-elevation myocardial infarction [NSTEMI]) of recent onset.
Conditions
Brief summary
Percent change in LDL-C from baseline to Day 150
Detailed description
• Participants achieving LDL-C <70 mg/dL (yes, no) at Day 150 • Participants achieving LDL-C <55 mg/dL (yes, no) at Day 150 • Participants achieving LDL-C <100 mg/dL (yes, no) (among the subset of participants with LDL-C ≥100 mg/dL at baseline) at Day 150 • Participants achieving ≥50% reduction from baseline in LDL-C (yes, no) at Day 150, • Percent change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) • Absolute change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) • Percent change in LDL-C from baseline to Day 30 and Day 90 • Absolute change in LDL-C from baseline to Day 30, Day 90 and Day 150, Percent change and absolute change in PCSK9 from baseline to Day 30, Day 90 and Day 150, Percent change and absolute change from baseline in: apoB, VLDL, non-HDLC, HDL-C, total cholesterol and triglycerides at Day 150, Number and percentage of participants experiencing treatment emergent AEs or SAEs
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in LDL-C from baseline to Day 150 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Participants achieving LDL-C <70 mg/dL (yes, no) at Day 150 • Participants achieving LDL-C <55 mg/dL (yes, no) at Day 150 • Participants achieving LDL-C <100 mg/dL (yes, no) (among the subset of participants with LDL-C ≥100 mg/dL at baseline) at Day 150 • Participants achieving ≥50% reduction from baseline in LDL-C (yes, no) at Day 150, • Percent change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) • Absolute change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) • Percent change in LDL-C from baseline to Day 30 and Day 90 • Absolute change in LDL-C from baseline to Day 30, Day 90 and Day 150, Percent change and absolute change in PCSK9 from baseline to Day 30, Day 90 and Day 150, Percent change and absolute change from baseline in: apoB, VLDL, non-HDLC, HDL-C, total cholesterol and triglycerides at Day 150, Number and percentage of participants experiencing treat | — |