Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000463471
Ethics application status
Approved
Date submitted
4/04/2025
Date registered
15/05/2025
Date last updated
15/05/2025
Date data sharing statement initially provided
15/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Triggered Acute Risk Prevention (TARP): Effect of a Novel Model of Care on Cardiovascular and Mental Health Outcomes.
Scientific title
Triggered Acute Risk Prevention (TARP): Effect of A Novel Model of Care on Cardiovascular and Mental Health Outcomes in Patients with Risk Factors for, or Known Cardiovascular Disease
Secondary ID [1] 313281 0
None
Universal Trial Number (UTN)
Trial acronym
TARP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 335610 0
Emotional Stress 335613 0
Trigger events 335614 0
Heart attack 336039 0
Heart disease 336040 0
Coronary artery disease 336041 0
Mental health 337327 0
Condition category
Condition code
Cardiovascular 332175 332175 0 0
Coronary heart disease
Cardiovascular 333406 333406 0 0
Other cardiovascular diseases
Mental Health 333407 333407 0 0
Anxiety
Mental Health 333408 333408 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An in-person appointment will be scheduled with site research nurse and potential participant, at which eligibility criteria will be confirmed, informed consent obtained and baseline characteristics and assessment performed.

A one-month run-in phase shall commence following this appointment, with simulated medication administration and trigger entry in study app. Participant contacted weekly during this period, and data reviewed at three weeks (max four) for adherence. Suitable participants able to continue to randomised study phase.

Suitable participants will be randomly allocated to TARP active or placebo intervention.

TARP Active
At the time, or after a participant experiences a trigger event, they will enter the following details into the study App, and be directed to respond according to the trigger severity level entered:
1. Trigger type (acute anger, emotional stress, heavy exertion, heavy meals, respiratory infection, or pollution) and severity
2. Cause of trigger
3. Date and Time of triggering event
4. Current heart rate at time of entering trigger
5. Medication taken, date and time taken (if medication required according to severity entered)

If level of risk is above a pre-set threshold, the App will direct the participant to take the study medicines:
• Blue packet containing propranolol and aspirin for acute anger, emotional stress and heavy exertion,
• Yellow packet containing aspirin for heavy meals, respiratory infection and pollution.

Medication Dosage and Route of Administration
TARP active dosage is:
Propranolol 10mg orally and Aspirin 100mg orally as required, with one repeat dosage allowed 4 hours or more after first dose, to a maximum of 2 doses per day,
OR
Aspirin 100mg orally as required, once per day.

Participants will receive a follow-up reminder at 2 hours post medication administration (according to the time taken entered at step 5 above). They will be asked to enter their current heart rate and current rating of trigger severity at time of entering follow-up.

The approximate duration of time taken to engage with the study app on each occasion should be 5 minutes or less.

If level of risk is below a pre-set threshold, the App will direct the participant that:
"This level of (trigger name) does not require study medication or need to be entered into the App. If your level of (trigger name) increases please re-assess the trigger using the App as your medication requirement may change. We recommend you visit the Education Portal for useful information on managing anger and wellbeing."

Adherence will be monitored by the Investigators through the App Management console, with app analytics evaluated for all data captured during participant trigger entry (steps 1-5). In addition, monthly phone interviews will be conducted by Research Nurse with study participants to collect information on participant experiences.

The study consists of a one-month run-in phase, and a 6-month active randomised (medication or placebo) study period.
Intervention code [1] 329856 0
Prevention
Comparator / control treatment
Placebo
At the time, or after a participant experiences a trigger event, they will enter details into the study App, and be directed to respond according to the level entered. If the level of risk is above a pre-set threshold, the App will direct participant to take:
• Blue packet containing placebos (matched to propranolol and aspirin) for acute anger, emotional stress and heavy exertion,
• Yellow packet containing placebo (matched to aspirin) for heavy meals, respiratory infection and pollution.

Dosage and Route of Administration
Placebo will be inactive products matched to study medicines with the same dosing regimen.

Composition of the placebo will be the following standard USP grade tablet excipients: Microcrystalline Cellulose, Colloidal Silicon Dioxide, Sodium Starch Glycolate, Sodium Stearyl Fumarate.

Participants will receive a follow-up reminder at 2 hours post placebo administration (according to the time taken entered at step 5 above). They will be asked to enter their current heart rate and current rating of trigger severity at time of entering follow-up.

The approximate duration of time taken to engage with the study app on each occasion should be 5 minutes or less.

If level of risk is below a pre-set threshold, the App will direct the participant that:
"This level of (trigger name) does not require study medication or need to be entered into the App. If your level of (trigger name) increases please re-assess the trigger using the App as your medication requirement may change. We recommend you visit the Education Portal for useful information on managing anger and wellbeing."

Adherence will be monitored by the Investigators through the App Management console, with app analytics evaluated for all data captured during participant trigger entry (steps 1-5). In addition, monthly phone interviews will be conducted by Research Nurse with study participants to collect information on participant experiences.

The study consists of a one-month run-in phase, and a 6-month active randomised (medication or placebo) study period.
Control group
Placebo

Outcomes
Primary outcome [1] 340398 0
The primary efficacy measure will be any change in anger and stress for active medication compared to placebo. This will be assessed as a composite outcome.
Timepoint [1] 340398 0
Level of anger and/or stress and heart rate measured at time of trigger event and two hours after medication administration.
Primary outcome [2] 340952 0
Screening-to-randomisation rate primary feasibility measure for the large endpoint-based trial.
Timepoint [2] 340952 0
Measured at three (max four) week timepoint in the study run-in phase.
Primary outcome [3] 341308 0
Participants remain in the trial at 6 months primary feasibility measure for the large endpoint-based trial.
Timepoint [3] 341308 0
6 months post randomisation
Secondary outcome [1] 445456 0
*THIS IS AN ADDITIONAL PRIMARY OUTCOME: Frequency of triggers primary feasibility measure for the the large endpoint-based trial
Timepoint [1] 445456 0
Monthly, from month one to month six, during the randomised study period
Secondary outcome [2] 445598 0
Trend for any change in CVD* endpoints in active TARP therapy versus placebo. This will be measured as a composite outcome. *Composite CVD endpoints comprise: Cardiovascular disease (CVD) related death (including sudden death), Non-fatal myocardial infarction (MI), unstable angina, Fatal and non-fatal stroke, transient ischemic attack (TIA), Takotsubo, Spontaneous Coronary Artery Dissection (SCAD), Aortic Dissection, Atrial fibrillation requiring medical review.
Timepoint [2] 445598 0
Monthly and at 6 months post-commencement of randomised study period
Secondary outcome [3] 447141 0
Frequency and acceptability of taking TARP medication
Timepoint [3] 447141 0
Monthly and at 6-months post commencement of intervention

Eligibility
Key inclusion criteria
• Age >=40 years with >=2 risk factors or known cardiovascular disease.
Risk factors: hypertension, hypercholesterolemia, current smoker, diabetes, positive family history (parents or siblings), atherosclerosis on CT coronary angiogram.
atherosclerosis on CT coronary angiogram.
• History of Takotsubo cardiomyopathy, SCAD, Ischemic stroke, TIA, stenosis>25% on carotid ultrasound.
• Ownership of a smartphone (capable of downloading the study app).
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Known contraindication or allergy to aspirin.
• Known contraindication or allergy to beta blocker medications.
• Current continuous use of anti-platelet drug or anticoagulant besides aspirin.
• Current treatment with a beta blocker or other heart rate lowering drug or anti-arrhythmic.
• Current clinical diagnosis of atrial fibrillation.
• Current heart rate <55bpm OR blood pressure <110/70mmHg.
• Current diagnosis of anaemia (haemoglobin level below the normal for the gender of participant - Hb<125g/L in men, <115g/L in women).
• Current, recurrent or previous condition with a high risk of / active major bleeding (eg cerebral aneurysm or cerebral AV malformation, gastrointestinal malignancy, recent peptic ulcer, liver disease, oesophageal varicosities, uraemia, aortic aneurysm, GI bleeding, intracerebral bleeding).
• Unstable diabetes or asthma.
• Newly diagnosed mental health illness (within last 3 months); exacerbation of known mental illness (within last 3 months); change of medication or modification in dose for mental illness (within the last 3 months).
• Cognitive impairment.
• Currently pregnant or planning to fall pregnant within study period (next 6 months).
• Investigator discretion.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be managed off-site at a central administration location. Allocation involves the site research staff contacting the holder of the allocation schedule at central administration site (Syntro Pharmacy) who will allocate the next kit number in order of the randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation using GraphPad Prism randomisation software to allocate participant numbers into two groups (Group A and Group B) in a 1:1 ratio
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
28/02/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27682 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 27683 0
Westmead Hospital - Westmead
Recruitment hospital [3] 27684 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 43859 0
2065 - St Leonards
Recruitment postcode(s) [2] 43860 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 317729 0
Charities/Societies/Foundations
Name [1] 317729 0
Ramsay Hospital Research Foundation
Country [1] 317729 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 320045 0
None
Name [1] 320045 0
Address [1] 320045 0
Country [1] 320045 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316419 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316419 0
Ethics committee country [1] 316419 0
Australia
Date submitted for ethics approval [1] 316419 0
28/10/2024
Approval date [1] 316419 0
08/04/2025
Ethics approval number [1] 316419 0
2024/ETH02331

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137830 0
Prof Geoffrey Tofler
Address 137830 0
Department of Cardiology, Level 5A, Acute Services Building, Royal North Shore Hospital, Pacific Hwy, St Leonards NSW 2065
Country 137830 0
Australia
Phone 137830 0
+61 2 9463 1514
Fax 137830 0
Email 137830 0
[email protected]
Contact person for public queries
Name 137831 0
Geoffrey Tofler
Address 137831 0
Department of Cardiology, Level 5A, Acute Services Building, Royal North Shore Hospital, Pacific Hwy, St Leonards NSW 2065
Country 137831 0
Australia
Phone 137831 0
+61 2 9463 1514
Fax 137831 0
Email 137831 0
[email protected]
Contact person for scientific queries
Name 137832 0
Geoffrey Tofler
Address 137832 0
Department of Cardiology, Level 5A, Acute Services Building, Royal North Shore Hospital, Pacific Hwy, St Leonards NSW 2065
Country 137832 0
Australia
Phone 137832 0
+61 2 9463 1514
Fax 137832 0
Email 137832 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: To maintain privacy and confidentiality, only aggregate data will be shared publicly



What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.