VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN)

NCT05834673 | Terminated

• 1 other identifier: CKJX839A1AU03R
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Hyperlipidaemia; Atherosclerotic Cardiovascular Disease (ASCVD); Hypercholesterolaemia; Lipid lowering therapies; Secondary Cardiovascular Prevention; New Model of Care; Nurse-Led Support Calls; Guideline Directed Management therapy (GDMT); The European Society of Cardiology (ESC) Guidelines

Outcome Measures

Primary Outcomes (1)

• Effect on LDL-C Concentration

  LDL-C concentration at baseline and at day 180

  Baseline and 180 Days

Secondary Outcomes (1)

• Effect on LDL-C Concentration

  365 Days

Other Outcomes (15)

• Patient satisfaction- Client Satisfaction Questionnaire

  Baseline,180 and 365 Days

• Patient Activation Measure

  Baseline,180 and 365 Days

• LDL-C Concentration control

  90 and 270 Days

Study Arms (2)

Usual Care Model

OTHER

Usual care arm : The GPs will be educated on the ESC guidelines and Guideline Directed Management therapy (GDMT) Inclisiran is available for this arm

Other: GP Education

New Model of Care

OTHER

Model of care arm The GPs will be educated on the ESC guidelines and Guideline Directed Management therapy (GDMT) The Participants enrolled via these sites arm will be getting receive monthly SMS messages with regards to regarding cardiovascular health and appointment reminders (low touch engagement nudges) In addition, 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. Inclisiran is available for this arm.

Other: SMS messages; Other: Telephone-based support calls; Other: GP Education

Interventions

SMS messages OTHER

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

Also known as: Monthly Text Messages

New Model of Care

Telephone-based support calls OTHER

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.

Also known as: Nurse Support Calls

New Model of Care

GP Education OTHER

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

New Model of Care; Usual Care Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study
• Males and females ≥18 years of age
• Documented History of ASCVD
• a. Coronary heart disease (CHD):
• Prior myocardial infarction
• Prior coronary revascularisation (PCI or CABG)
• b. Cerebrovascular disease:
• Prior documented ischaemic stroke
• Documented Carotid artery stenosis \>70%
• History of prior percutaneous or surgical carotid artery revascularisation.
• c. Peripheral arterial disease (PAD):
• History of prior percutaneous or surgical revascularisation of an iliac, femoral, or popliteal artery or aortic aneurysm in electronic patient history
• Prior surgical amputation of a lower extremity due to peripheral artery disease.
• OR ASCVD risk equivalents as per assessed by the online tool (\>10% probability of CVD event within the next 5 years www.cvdcheck.org.au/calculator) or at clinically determined high risk.
• Serum LDL-C above target ≥1.8 mmol/L (≥70 mg/dL) for ASCVD patients or ≥2.0 mmol/L for ASCVD risk equivalent patients

You may not qualify if:

• Any medical or surgical history and or condition that might limit the individual's ability to take part in the study and/or put the participant at significant risk (according to physician's judgment).
• Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the physician might interfere with the interpretation of the study results, including pregnancy.
• Previous, current, or planned treatment with a monoclonal antibody targeting PCSK9.
• Participants unable to access or unwilling to use mobile phone to receive text messages and/or questionnaires as proposed in the new model of care.
• Participants who plan to move away from the geographical area where the study is being conducted during the study period.

Sponsors & Collaborators

• Monash University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Manningham General Practice, 200 High St, Templestowe Lower

Melbourne, Victoria, 3107, Australia

Location

MeSH Terms

Conditions

Atherosclerosis; Coronary Disease; Cerebrovascular Disorders; Peripheral Arterial Disease; Hyperlipidemias; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Peripheral Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stephen Nicholls

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director of MonashHeart, Intensive Care and Victorian Heart Hospital

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: April 28, 2023
• Study Start: November 17, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)