VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN)

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.

Conditions

• Atherosclerotic Cardiovascular Disease (ASCVD)
• Coronary Heart Disease (CHD)
• Cerebrovascular Disease
• Peripheral Arterial Disease (PAD)

Interventions

OTHER

SMS messages

Participants will receive monthly SMS messages regarding cardiovascular health (low touch engagement nudges)

OTHER

Telephone-based support calls

Participants will receive telephone-based support calls from a study nurse trained in motivational interviewing. These telephone calls will cover diet, exercise, medication, and where necessary smoking cessation. A summary of any recommendations will then be sent to the primary care physician via email or letter.

OTHER

GP Education

Education of GPs on the European Society of Cardiology (ESC) guidelines and Guideline Directed Management Therapy

Sponsors & Collaborators

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• Monash University

  lead OTHER

Principal Investigators

• Stephen Nicholls · Monash University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-17

Primary Completion

2024-12-19

Completion

2024-12-19

Countries

• Australia

Study Locations