Prevention of Reperfusion Injury in Myocardial infarction (PRIME) trial

Does Paracetamol decrease reperfusion injury to patients presenting with acute ST-elevation myocardial infarction when given prior to primary percutaneous intervention.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000409572

Acronym

PRIME

Enrollment

200

Registered

2024-04-04

Start date

2024-06-03

Completion date

Unknown

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results