Using platelet function analysis to personalise anti-thrombotic drug therapies

ISRCTN ISRCTN67917825
DOI https://doi.org/10.1186/ISRCTN67917825
IRAS number 357473
Secondary identifying numbers CPMS 69135
Submission date
16/06/2025
Registration date
16/06/2025
Last edited
16/07/2025
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Platelets are tiny cells in our blood that help stop bleeding by forming clots when blood vessels are damaged. But sometimes, they form clots when they shouldn’t. This can block blood flow and cause serious problems like heart attacks and strokes. Medicines that reduce clotting can help, but they also increase the risk of dangerous bleeding. Right now, doctors don’t have a good way to know which patients will benefit from these medicines and which might be harmed. This study is testing a new way to measure how platelets behave, to help doctors make better decisions about treatment. The goal is to see how well this test works in people who’ve had a type of heart attack called a non-STEMI.

Who can participate?
Adults aged 18 or over who have been diagnosed with a non-STEMI heart attack.

What does the study involve?
Participants will have their platelet function tested three times:
-When they are admitted to hospital
-Around two months later (when they are likely taking two anti-clotting medicines)
-At 12 months (after one of the medicines has been stopped)
These tests will help researchers understand how platelets behave over time and how this relates to treatment.

What are the possible benefits and risks of participating?
Taking part may not directly benefit participants, but it could help improve treatment for future patients. The risks are low, but as with any blood test, there may be minor discomfort or bruising.

Where is the study run from?
University of Reading (UK)

When is the study starting and how long is it expected to run for?
June 2025 to August 2030.

Who is funding the study?
British Heart Foundation

Who is the main contact?
Jonathan Gibbins, j.m.gibbins@reading.ac.uk

Contact information

Prof Jonathan Gibbins
Public, Scientific, Principal Investigator

University of Reading, School of Biological Sciences, Health and Life Sciences Building
Reading
RG6 6EX
United Kingdom

ORCiD logoORCID ID 0000-0002-0372-5352
Phone +44 1183787082
Email j.m.gibbins@reading.ac.uk

Study information

Study designSingle-centre longitudinal observational analysis of platelet function using Platelet Phenomic Analysis to refine its use for personalisation of anti-platelet therapy in patients diagnosed with non-STEMI myocardial infarction.
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeDiagnostic, Screening
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titlePLatelet phenomics Analysis to guide patient Stratification and anti-platelet Medication In acute Coronary syndrome
Study acronymPLASMIC
Study objectivesPlatelet Phenomic Analysis can guide therapeutic choices for patients with acute coronary syndrome
Ethics approval(s)

Submitted 09/06/2025, West Midlands - Edgbaston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048137; edgbaston.rec@hra.nhs.uk), ref: 25/WM/0133

Health condition(s) or problem(s) studiedAcute coronary syndrome: non-STEMI myocardial infarction
InterventionPlatelet phenomics analysis to be performed at admission, at approximately 2 months (when likely to be on dual anti-platelet therapy) and at 12 months following removal of second anti-platelet agent
Intervention typeOther
Primary outcome measurePlatelet phenomics analysis to assess impact of inherent platelet function capacity on responses to single and dual anti-platelet therapies at baseline, 2 months, 12 months
Secondary outcome measuresPharmacogenomic analysis to determine impact on platelet function responses (measured by Platelet Phenomic Analysis) of different anti-platelet agents at baseline, 2 months, 12 months
Overall study start date16/06/2025
Completion date31/08/2030

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit100 Years
SexBoth
Target number of participants400
Key inclusion criteriaDiagnosis of non-STEMI myocardial infarction
Key exclusion criteriaPatients already taking P2Y12 antagonists, pregnancy, active or recent malignancy, and renal, liver or other haematological pathologies
Date of first enrolment01/01/2026
Date of final enrolment01/07/2028

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Berkshire Hospital NHS Foundation Trust
University Department of Cardiology
Craven Road
Reading
RG1 5AN
United Kingdom

Sponsor information

University of Reading
University/education

Whiteknights House, Whiteknights
Reading
RG6 6AH
England
United Kingdom

Phone +44 1183225111
Email a.j.davy@reading.ac.uk
Website https://www.reading.ac.uk
ROR logo "ROR" https://ror.org/05v62cm79

Funders

Funder type

Charity

British Heart Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
the_bhf, The British Heart Foundation, BHF
Location
United Kingdom

Results and Publications

Intention to publish date31/08/2030
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planTo be published in leading open-access academic journals. Press releases will be used for wider public engagement and education. Adoption of tests to be in collaboration with HaemAnalytica Ltd.
IPD sharing planBrief report aimed at participants will be available at the conclusion of the study.
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
j.m.gibbins@reading.ac.uk (Jonathan Gibbins)
Platelet function analysis – raw and processed using our open source and publicly available software. This will not make much sense without our prior analysis and will form the basis of our future patient stratification procedures. Thus the most helpful way to access with be via email and with our support.
Data will be available from point of publication and will be available in perpetuity via UoReading research data repository.
Likely to be helpful for other groups interest in patient stratification based on platelet function analysis using our analytical systems.
Consent was obtained.
No legal restrictions at this point, although if this forms the basis of new IP protection, this may slow down sharing. Protection of IP will be necessary to support commercialisation that will be essential for wide adoption in the longer term.

Editorial Notes

16/07/2025: Internal review.
16/06/2025: Trial's existence confirmed by British Heart Foundation.