Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001100583
Ethics application status
Approved
Date submitted
18/06/2024
Date registered
12/09/2024
Date last updated
12/09/2024
Date data sharing statement initially provided
12/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Determine the Effects of Dual Anti-Platelet Therapy (DAPT) on Neutrophils.
Scientific title
A Study to Determine the Effects of in vivo Dual Anti-Platelet Therapy (DAPT) on Neutrophils.
Secondary ID [1] 312358 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neutrophil response to aspirin and ticagrelor in healthy volunteers 335023 0
Condition category
Condition code
Inflammatory and Immune System 330813 330813 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dual antiplatelet therapy (DAPT): Acetylsalicylic acid (Aspirin) and ticagrelor.

The proposed study is to investigate whether neutrophils are affected by dual antiplatelet therapy.
Participants will receive DAPT (oral tablets) for a total of seven days. Participants will receive a combination of Acetylsalicylic acid (300 mg loading dose on day 1, 100 mg maintenance dose on days 2 – 7) and ticagrelor (180 mg loading dose on day 1, 90 mg maintenance dose on days 1 – 7). This treatment regime mimics the routine administration of DAPT for acute myocardial infarction (AMI) patients in Aotearoa New Zealand. Adherence to medication will be recorded by participants (date and time of dose) and checked by the study researchers at each study visit. Participants are also informed that non-adherence at any point during the 7 day study period will result in withdrawal from the study.

After Day 1 (loading doses), participants will self-administer DAPT and record timing and dates of each dose in a provided form. Participants can also choose to be notified when it is time to take their next dose of DAPT.
Intervention code [1] 328855 0
Treatment: Drugs
Comparator / control treatment
A blood sample will be collected from each participant pre-intervention (DAPT) and this sample will act as a control and no additional treatment arm is required.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338577 0
Neutrophil immunophenotyping
Timepoint [1] 338577 0
Baseline, 24-hours post-commencement of DAPT, 7-days post-commencement of DAPT.
Primary outcome [2] 339278 0
Phagocytosis capacity
Timepoint [2] 339278 0
Baseline, 24-hours post-commencement of DAPT, 7-days post-commencement of DAPT.
Primary outcome [3] 339279 0
Superoxide anion production
Timepoint [3] 339279 0
Baseline, 24-hours post-commencement of DAPT, 7-days post-commencement of DAPT.
Secondary outcome [1] 436495 0
Platelet function
Timepoint [1] 436495 0
24-hours post-commencement of DAPT, 7-days post-commencement of DAPT.
Secondary outcome [2] 439348 0
Release of soluble mediators
Timepoint [2] 439348 0
Baseline, 24-hours post-commencement of DAPT, 7-days post-commencement of DAPT.

Eligibility
Key inclusion criteria
Self-reporting healthy individuals.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pre-existing immune, cardiovascular or platelet disorders, diabetes mellitus, active malignancy, pregnancy, acute illness or vaccination within six weeks prior to recruitment, treatment with cardiovascular or immune-modulating medications within seven days prior to recruitment, or a previous adverse drug reaction to either Acetylsalicylic acid or ticagrelor.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2025
Actual
Date of last data collection
Anticipated
8/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26383 0
New Zealand
State/province [1] 26383 0
Wellington

Funding & Sponsors
Funding source category [1] 316766 0
Charities/Societies/Foundations
Name [1] 316766 0
Wellington Medical Research Foundation
Country [1] 316766 0
New Zealand
Primary sponsor type
University
Name
Victoria University of Wellington
Address
Country
New Zealand
Secondary sponsor category [1] 318980 0
None
Name [1] 318980 0
Address [1] 318980 0
Country [1] 318980 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315533 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 315533 0
Ethics committee country [1] 315533 0
New Zealand
Date submitted for ethics approval [1] 315533 0
27/06/2024
Approval date [1] 315533 0
29/08/2024
Ethics approval number [1] 315533 0
2024 EXP 19948

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

Contacts
Principal investigator
Name 134994 0
Ms Ceridwyn Jones
Address 134994 0
Victoria University Clinical Research Laboratory, Level 8 CSB, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington 6021.
Country 134994 0
New Zealand
Phone 134994 0
+64273712175
Fax 134994 0
Email 134994 0
[email protected]
Contact person for public queries
Name 134995 0
Ceridwyn Jones
Address 134995 0
Victoria University Clinical Research Laboratory, Level 8 CSB, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington 6021.
Country 134995 0
New Zealand
Phone 134995 0
+64273712175
Fax 134995 0
Email 134995 0
[email protected]
Contact person for scientific queries
Name 134996 0
Ceridwyn Jones
Address 134996 0
Victoria University Clinical Research Laboratory, Level 8 CSB, Wellington Regional Hospital, 49 Riddiford Street, Newtown, Wellington 6021.
Country 134996 0
New Zealand
Phone 134996 0
+64273712175
Fax 134996 0
Email 134996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.