VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN)

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Monash University
• Collaborator: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study

2. Males and females ≥18 years of age

3. Documented History of ASCVD

a. Coronary heart disease (CHD):

1. Prior myocardial infarction

2. Prior coronary revascularisation (PCI or CABG)

b. Cerebrovascular disease:

1. Prior documented ischaemic stroke

2. Documented Carotid artery stenosis >70%

3. History of prior percutaneous or surgical carotid artery revascularisation.

c. Peripheral arterial disease (PAD):

1. History of prior percutaneous or surgical revascularisation of an iliac, femoral, or popliteal artery or aortic aneurysm in electronic patient history

2. 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.

4. 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

5. Not at Guideline directed cholesterol goals

6. On a stable dose of lipid-lowering therapy (such as a statin and/or ezetimibe) for ≥30 days before screening with no planned medication or dose change. Statin intolerant patients are eligible if intolerance is documented.

Exclusion Criteria:

1. 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).

2. 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.

3. Previous, current, or planned treatment with a monoclonal antibody targeting PCSK9.

4. 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.

5. Participants who plan to move away from the geographical area where the study is being conducted during the study period.