A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of an "Inclisiran First" Implementation Strategy to Usual Care on LDL Cholesterol (LDL-C) in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C (≥70 mg/dL) Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE) (V-INITIATE)
The purpose of this study is to assess the effectiveness of an "inclisiran first"
implementation strategy (addition of inclisiran to maximally tolerated statin therapy
immediately upon failure to achieve acceptable LDL-C with maximally tolerated statin therapy
alone) compared to usual care in an ASCVD population.
The study design will be a randomized, two-arm, parallel-group, open-label, multicenter,
clinical trial comparing an "inclisiran first" implementation strategy to usual care in
approximately 444 participants (1:1 randomization) with established ASCVD and elevated LDL-C
(or non-HDL-C) despite treatment with maximally tolerated statin therapy.
The study will include male and female participants ≥18 years of age with a history of ASCVD
(coronary heart disease, ischemic cerebrovascular disease or peripheral arterial disease) who
have elevated LDL-C (≥70 mg/dL) or non-HDL-C (≥100 mg/dL) despite being treated with
maximally tolerated statin therapy. A total of approximately 444 participants will be
randomized to the "inclisiran first" implementation strategy or usual care in a 1:1 ratio at
approximately 40 US sites.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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