Title: A randomized, double-blinded, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT)
- Principal Investigator: Dr. Jiafu Ou
- Study Coordinator / Research Nurse: Maureen Dempsey
This study is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 2, Day 90, and every 6 months thereafter taken in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce te risk of 4-Point Major Adverse Cardiovascular Events 4P-MACE) defined A composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
The primary 70mg/dL0 objective of this study is to demonstrate the superiority of inclisrian compared to placebo in reducing the risk of 4P-MACE (composite of CV death, non-fatal MI, urgent coronary revascularization and non-fatal ischemic stroke) in participants with LDL-C >1.8 mmol/L (70mg/dl) without a prior ASCVD event. Also, the study is hoping to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of cardiovascular death. If the findings of this study do prove the inclisiran has an effect of decreasing cardiovascular death and ASCVD’s it would be a change in standard of care for veterans.
This study is administered by VREF and funded by Novartis.
Find Out More
This study is actively enrolling patients. To learn more about VICTORIAN-1 and how you can join contact our research office at (314) 289-7690.
If you are a veteran receiving care through the VA St. Louis Health Care System and believe you may be eligible for this study, please speak with your Physician. For general information about our research, please visit our main Clinical Trials page or contact us directly.