Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000409572p
Ethics application status
Not yet submitted
Date submitted
14/03/2024
Date registered
4/04/2024
Date last updated
4/04/2024
Date data sharing statement initially provided
4/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevention of Reperfusion Injury in Myocardial infarction (PRIME) trial
Scientific title
Does Paracetamol decrease reperfusion injury to patients presenting with acute ST-elevation myocardial infarction when given prior to primary percutaneous intervention.
Secondary ID [1] 311736 0
Nil
Universal Trial Number (UTN)
Trial acronym
PRIME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ST-Elevation Myocardial Infarction 333218 0
Condition category
Condition code
Cardiovascular 329908 329908 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients presenting with acute ST-Elevation Myocardial Infarction (STEMI) to Waikato Hospital, who will be treated with Primary Percutaneous Coronary Intervention (PCI) with in four hours, will be given 1.5g of Paracetamol oral tablets prior to PCI and then 1g regularly four times a day, for four days afterwards. This will be recorded on the patient hospital drug chart.
Intervention code [1] 328194 0
Treatment: Drugs
Comparator / control treatment
Historical control data from the ANZACS-QI data base to compare to primary and secondary treatment outcomes. The data will be taken from the two year period prior to the start of the trial.
Control group
Historical

Outcomes
Primary outcome [1] 337673 0
Peak troponin level
Timepoint [1] 337673 0
Day 1, 2, 3, 4 post PCI
Secondary outcome [1] 432793 0
Incidence of ventricular arrhythmia
Timepoint [1] 432793 0
Continuous monitoring during the patients stay in hospital of Day 1, 2, 3, 4 post PCI.
Secondary outcome [2] 432794 0
30-day Mortality rate
Timepoint [2] 432794 0
Day 30 post PCI
Secondary outcome [3] 432795 0
left ventricular ejection fraction
Timepoint [3] 432795 0
prior to discharge from hospital

Eligibility
Key inclusion criteria
Patients presenting to Waikato Hospital with acute ST-Elevation Myocardial Infarction (STEMI) on Electrocardiogram (ECG), as interpreted by Emergency Department (ED) or Cardiology Senior Medical Officer (SMO) or Senior Registrar.
The patient will then be discussed with the on-call Cardiac interventionalist, if the best treatment for the patient is judged to be primary percutaneous intervention (PCI) within the next 4 hours, the enrollment process can then be started.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to Paracetamol
Known liver failure (Child-Pugh class C)
GCS less than 15
Unable to swallow tablets – ie. intubated or too medically unwell to safely swallow tablets.

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
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 26200 0
New Zealand
State/province [1] 26200 0

Funding & Sponsors
Funding source category [1] 316067 0
Hospital
Name [1] 316067 0
Te Whatu Ora Waikato
Country [1] 316067 0
New Zealand
Primary sponsor type
Hospital
Name
Te Whatu Ora Waikato
Address
Country
New Zealand
Secondary sponsor category [1] 318234 0
None
Name [1] 318234 0
Address [1] 318234 0
Country [1] 318234 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314885 0
Health and Disability Ethics Committee
Ethics committee address [1] 314885 0
adrian.owen@waikatodhb.health.nz
Ethics committee country [1] 314885 0
New Zealand
Date submitted for ethics approval [1] 314885 0
30/04/2024
Approval date [1] 314885 0
Ethics approval number [1] 314885 0

Summary
Brief summary
This study will investigate if giving Paracetamol to patients presenting with a myocardial infarction decreases the size of the infarction and the complications of the infarction. These benefits would be due to Paracetamol protecting the myocardium from reperfusion injury, which can make up to half the total myocardial damage sustained in myocardial infarction.
The study will enroll patients who present with a myocardial infarction that can be treated with primary percutaneous intervention (PCI). They will be given 1.5g prior to PCI, and then 1g, four times a day, for four days afterwards.
Serum Troponins will be taken each day, and the peak Troponin will used as the primary outcome measure. Patients will be monitored for Ventricular Arrhythmias, which occur during reperfusion injury, and will have an Echocardiogram performed to assess for heart function. 30 day mortality will also be recorded.
These values will be compared to a historical control taken from the ANZACS-QI data base.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133058 0
Dr Adrian Owen
Address 133058 0
Waikato Hospital, 183 Pembroke Street, Hamilton 3204
Country 133058 0
New Zealand
Phone 133058 0
+64221885215
Fax 133058 0
Email 133058 0
adrian.owen@waikatodhb.health.nz
Contact person for public queries
Name 133059 0
Adrian Owen
Address 133059 0
Waikato Hospital, 183 Pembroke Street, Hamilton 3204
Country 133059 0
New Zealand
Phone 133059 0
+64221885215
Fax 133059 0
Email 133059 0
adrian.owen@waikatodhb.health.nz
Contact person for scientific queries
Name 133060 0
Adrian Owen
Address 133060 0
Waikato Hospital, 183 Pembroke Street, Hamilton 3204
Country 133060 0
New Zealand
Phone 133060 0
+64221885215
Fax 133060 0
Email 133060 0
adrian.owen@waikatodhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
meta-analysis
How or where can data be obtained?
access subject to approvals by Principal Investigator, adrian.owen@waikatodhb.health.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21871Study protocol    387500-(Uploaded-14-03-2024-08-13-49)-Study-related document.docx



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.