|Problem||ACS with scheduled PCI|
|Inclusion criteria||The inclusion criteria for patients with unstable angina or non–ST-elevation myocardial infarction were ischemic symptoms lasting 10 minutes or more and occurring within 72 hours before randomization, a TIMI risk score of 3 or more, and either ST-segment deviation of 1 mm or more or elevated levels of a cardiac biomarker of necrosis.
Patients with ST-elevation myocardial infarction could be enrolled within 12 hours after the onset of symptoms if primary PCI was planned or within 14 days after receiving medical treatment for ST-elevation myocardial infarction.
|Exclusion criteria||Key exclusion criteria included an increased risk of bleeding, anemia, thrombocytopenia, a history of pathologic intracranial findings, or the use of any thienopyridine within 5 days before enrollment.|
|Primary endpoint||Composite of death from cardiovascular causes, nonfatal MI or nonfatal stroke|
|Secondary endpoint(s)||Key secondary end points at 30 and 90 days were the primary composite end point and a composite of death from cardiovascular causes, nonfatal myocardial infarction, or urgent target-vessel revascularization. Key secondary end points for the entire follow-up period were stent thrombosis and a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or rehospitalization due to a cardiac ischemic event. Additional prespecified analyses included an analysis of the rates of the primary end point from randomization to day 3 and a landmark analysis of those data from day 3 to the end of the study. Key safety end points were TIMI major bleeding not related to coronary-artery bypass grafting (CABG), non–CABG-related TIMI life-threatening bleeding, and TIMI major or minor bleeding, as previously defined.|
|Brief summary:||Prasugrel superior to clopidogrel in ACS scheduled for PCI|
|PAPER: Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes|
|Date||15 Nov 2007|
|Journal||N Engl J Med. 2007 Nov 15;357(20):2001-15. Epub 2007 Nov 4.|
|Information||Prasugrel (vs. clopidogrel)
--Composite of death from cardiovascular causes, nonfatal MI or nonfatal stroke
--Urgent target vessel revascularisation
-Increased risk of bleeding
-Increased risk of life-threatening bleeding