| Protocol No: | ECCT/22/05/01 | Date of Protocol: | 08-07-2021 |
| Study Title: |
A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with
established cardiovascular disease
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| Study Objectives: |
Primary objective:
Inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal
ischemic stroke) in participants with established ASCVD and a LDL-C ≥1.8 mmol/L (70 mg/dL)
Secondary objective(s)
Inclisiran compared to placebo in reducing the risk of CV death.
Inclisiran compared to placebo in reducing the risk of 4P-MAC (composite of CV death, non-fatal MI, non-fatal ischemic
stroke and urgent coronary revascularization).
Inclisiran compared to placebo in reducing the risk of all-cause death.
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| Laymans Summary: |
A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular
disease.
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| Abstract of Study: |
Study CKJX839B12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1,
Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD
(atherosclerotic cardiovascular disease)will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of
CV death, non-fatal MI and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.
This is a multi-center, multi-country and event-driven study. Approximately 15,000 participants meeting the eligibility criteria will be randomized. Since 50%
screening failure rate is expected, approximately 30,000 participants are expected to be screened. Participants eligible for this trial will include male and female
participants age 40 years and older who (a) have established ASCVD, and, (b) an LDL-C 1≥.8 mmol/L (70 mg/dL) despite the use of high-intensity statin
therapy.
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