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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05834673




Registration number
NCT05834673
Ethics application status
Date submitted
20/02/2023
Date registered
28/04/2023
Date last updated
11/01/2024

Titles & IDs
Public title
VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN)
Scientific title
AtheroSclerotic Cardiovascular disEase Risk assessmenT and treAtment In AustraliaN Primary Care (VICTORION-ASCERTAIN: Implementation Study)
Secondary ID [1] 0 0
CKJX839A1AU03R
Universal Trial Number (UTN)
Trial acronym
v-ASCERTAIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease (ASCVD) 0 0
Coronary Heart Disease (CHD) 0 0
Cerebrovascular Disease 0 0
Peripheral Arterial Disease (PAD) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Inclisiran Prefilled Syringe
Other interventions - SMS messages
Other interventions - Telephone-based support calls

Other: Usual Care Model - 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: New Model of Care - 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.


Treatment: Drugs: Inclisiran Prefilled Syringe
Inclisiran, 284 mg, 1.5 ml Liquid in a single-use prefilled syringe (PFS) for s.c. administration and any standard medications to be used within registered indication and at the treating physician's discretion.

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

Other interventions: 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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effect on LDL-C Concentration
Timepoint [1] 0 0
Baseline and 180 Days
Secondary outcome [1] 0 0
Effect on LDL-C Concentration
Timepoint [1] 0 0
365 Days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Somerton Park Day & Night Medical Centre - Adelaide
Recruitment postcode(s) [1] 0 0
5044 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novartis Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05834673
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Nicholls
Address 0 0
Monash Heart
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Julie Butters
Address 0 0
Country 0 0
Phone 0 0
+61 434679018
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05834673