|Format||Double-blinded randomised multi-center controlled trial|
|Treatment||Pre-treatment with 30mg prasugrel before angiography. A further 30mg following angiography if felt appropriate for PCI.|
|Control||Placebo, with 60mg prasugrel post-angiography if for PCI|
|Inclusion criteria||Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor as per respective labels
May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel
Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital
|Exclusion criteria||Prior treatment with a P2Y12 receptor antagonist
Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization
Have cardiogenic shock
Have refractory ventricular arrhythmias
Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)
Have had cardiac arrest within 1 week of entry or randomization into the study
|Follow-up||7 and 30 days|
|Primary endpoint||Composite of the first occurrence of death from cardiovascular causes, myocardial infarction, stroke, urgent revascularization, or the need for rescue therapy with glycoprotein IIb/IIIa inhibitors (glycoprotein IIb/IIIa bailout) through day 7 after randomization|
|Secondary endpoint(s)||Composite of death from cardiovascular causes, myocardial infarction, or stroke
Death from any cause
Safety end points of major and minor bleeding according to Thrombolysis in Myocardial Infarction (TIMI) criteria were evaluated for all bleeding episodes and according to whether the bleeding was related or not related to CABG.
|Details||All patients received aspirin
Glycoprotein IIb/IIIa inhibitors used as bailout only;
|Brief summary:||Administering 30mg prasugrel prior to angiography in NSTEMI patients offered no benefit above delaying therapy until a lesion for PCI is identified on angiography|
|PAPER: Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes.|
|Date||12 Sep 2013|
|Journal||N Engl J Med. 2013 Sep 12;369(11):999-1010. doi: 10.1056/NEJMoa1308075.|
|Information||There is therefore no advantage to administering prasugrel prior to angiography in NSTEMI patients; pre-treatment with prasugrel (30mg) prior to angiographic identification did not reduce the composite of death from cardiovascular causes, myocardial infarction, stroke, urgent revascularization, or glycoprotein IIb/IIIa inhibitor rescue therapy.
There was no benefit in the 69% of patients who underwent PCI.
There was an increase in major bleeding in the pre-treatment group.