The early glycoprotein IIb/IIIa inhibition in non-ST-segment elevation acute coronary syndrome (EARLY ACS) trial: a randomized placebo-controlled trial evaluating the clinical benefits of early front-loaded eptifibatide in the treatment of patients with non-ST-segment elevation acute coronary syndrome--study design and rationale.
BACKGROUND
The recent North American and European practice guidelines in patients with non-ST-segment elevation acute coronary syndrome (nSTE ACS) recommend glycoprotein IIb/IIIa (GpIIb-IIIa) inhibition in patients undergoing an early invasive treatment strategy. However, the guidelines are not explicit regarding the timing of initiation of GpIIb-IIIa antagonists, and there is marked variation in clinical practice regarding their use.


METHODS
The EARLY ACS trial will enroll 10,500 patients in a prospective, randomized, double blind, international, multicenter investigation of early eptifibatide compared with placebo (with provisional eptifibatide in the catheterization laboratory) in patients with high-risk nSTE ACS in whom an invasive strategy is planned no sooner than the next calendar day. The primary efficacy end point is the 96-hour composite of all-cause mortality, nonfatal myocardial infarction, recurrent ischemia requiring urgent revascularization, or need for thrombotic bailout with GpIIb-IIIa inhibitor during percutaneous coronary intervention. The key secondary end point is the composite of death or nonfatal myocardial infarction within 30 days of enrollment.


CONCLUSIONS
The EARLY ACS trial will be the largest study to date to evaluate the utility of early GpIIb-IIIa inhibition in patients with nSTE ACS in whom an invasive approach is planned. This trial will provide important evidence regarding the benefit of initiating eptifibatide early after presentation with high-risk ACS versus delayed provisional use after coronary angiography. Furthermore, it will explore the ability of biomarkers to identify high-risk patients who may benefit from such an early aggressive approach.
Giugliano
Robert P
RP
TIMI Study Group, Boston, MA 02115, USA. rgiugliano@partners.org
Newby
L Kristin
LK
Harrington
Robert A
RA
Gibson
C Michael
CM
Van de Werf
Frans
F
Armstrong
Paul
P
Montalescot
Gilles
G
Gilbert
James
J
Strony
John T
JT
Califf
Robert M
RM
Braunwald
Eugene
E
D000208:Acute Disease; D000789:Angina, Unstable / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004562:Electrocardiography; D000077542:Eptifibatide; D006801:Humans; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000503:physiopathology; D010455:Peptides / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D013577:Syndrome; D013997:Time Factors
D010455:Peptides; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D000077542:Eptifibatide