None listed
Conditions
Brief summary
The PRIME II trial aims to show that giving Paracetamol to patients who present with STEMI reduces their total infarction size. The reduction will be produced by reducing the amount of reperfusion injury that occurs after the culprit artery is opened. If this trial is positive there would be a change to standard care of myocardial infarction, as well as further research into the exact mechanism of Paracetamol’s cardioprotective effect. This could lead to specific agents being produced to specifically target this mechanism of action.
Interventions
1.5g of Paracetamol, alongside current standard ST-elevation Myocardial Infarction (STEMI) treatment - dual anti-platelet therapy, analgesia, enoxaparin.
Patients who have already taken Paracetamol within four hours of diagnosis of STEMI will be given an extra dose of 500mg, if they took 1g, and then be included in the study.
Patients will then be given 1g of Paracetamol four times per day, for 2 days post Percutaneous Coronary Intervention, as well as their standard therapy as directed by thei
1.5g of Paracetamol, alongside current standard ST-elevation Myocardial Infarction (STEMI) treatment - dual anti-platelet therapy, analgesia, enoxaparin. Patients who have already taken Paracetamol within four hours of diagnosis of STEMI will be given an extra dose of 500mg, if they took 1g, and then be included in the study. Patients will then be given 1g of Paracetamol four times per day, for 2 days post Percutaneous Coronary Intervention, as well as their standard therapy as directed by their Cardiologist. This adherence will be monitored by auditing medication charts.
Sponsors
Te Whatu Ora
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients presenting to Waikato and Christchurch Hospitals Emergency Departments with Acute STEMI.
Exclusion criteria
Allergy to Paracetamol Known liver failure (Child-Pugh class C) Glasgow Coma Scale less than 15
Outcome results
None listed