HPS-4/TIMI 65/ORION-4: A double-blind randomized placebo controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease.

Brief description of study

This study is testing an investigational drug called inclisiran which lowers bad (LDL) cholesterol in the blood. Study doctors hope that giving this injection every 6 months for several years will lower the number of heart attacks and strokes, but they do not know this for certain. Inclisiran is given as an injection into the tissue just under the skin every 6 months, with an extra injection 3 months after starting the study drug. Inclisiran is currently not approved by the Food and Drug Administration (FDA) for use in the United States. In addition, this study will compare inclisiran with a placebo to see if receiving inclisiran is better than receiving a placebo. The placebo is a substance that looks like a drug, but has no drug in it.

Clinical Study Identifier: s18-01536
ClinicalTrials.gov Identifier: NCT03705234

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