VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN)
Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
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 study doctor or study staff as soon as possible about suspected participant /
participant partner pregnancy.
- Tell the study doctor or study staff if they change their mind about taking part in the
study.
- Attend all the visits (screening visit, visits 1, 2, 3, 4 and visit 5).
- Provide all the information that will enable the study team to contact them, i.e.,
inform the study staff if contact details change, provide contact details of a family
member, etc.