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VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN)

Monash University · 2023
ClinicalTrials.gov · Datasets · License: Public Domain · 2023
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The goal of this study is to understand and compare an alternative model of care in comparison to the usual model of care in include male and female participants ≥18 years of age with a history of ASCVD (hear and blood vessels diseases) or high-risk participants who have elevated bad cholesterol (LDL-C ≥1.8 mmol/L). The alternative model of care includes telephone support calls from a study nurse (after visits 1,2 and 4) and text messages to your mobile phone with healthy heart information. The main question it aims to answer is to understand and compare an alternative model of care in comparison to the usual model of care by evaluating the study participants bad cholesterol values after 180 and 365 days of the study. Each participant will take their medications as per usual care but may have the addition of Inclisiran, 284 mg 1.5 ml liquid in a single-use prefilled syringe for under skin administration. In accordance with the current medical practice guidelines for treating heart related conditions, Inclisiran and its product information will be made available for use in both care models. All the participants who decide to take part in this study will be requested to do the following: * Answer any questions from the study doctor or the study staff as accurately as possible when asked about changes in health status, medications, heart health, visits to other doctors or hospital admissions, planned surgery, even if they think none of these are related to the study. * Study doctor will be able to inform them of which medications you can and cannot take as part of this study. * To use mobile phone to receive text messages and/or questionnaires as proposed in the new model of care. * Advise the study doctor if they plan to move away from the geographical area where the study is being conducted during the study period. * Take the medications for cholesterol lowering treatment (such as a statin and/or ezetimibe) that are prescribed by the study doctor. * Tell the stud
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