PMID- 15976780
OWN - NLM
STAT- MEDLINE
DCOM- 20051128
LR  - 20181201
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 149
IP  - 6
DP  - 2005 Jun
TI  - 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.
PG  - 994-1002
AB  - 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. STUDY DESIGN: 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. IMPLICATIONS: 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.
FAU - Giugliano, Robert P
AU  - Giugliano RP
AD  - TIMI Study Group, Boston, MA 02115, USA. rgiugliano@partners.org
FAU - Newby, L Kristin
AU  - Newby LK
FAU - Harrington, Robert A
AU  - Harrington RA
FAU - Gibson, C Michael
AU  - Gibson CM
FAU - Van de Werf, Frans
AU  - Van de Werf F
FAU - Armstrong, Paul
AU  - Armstrong P
FAU - Montalescot, Gilles
AU  - Montalescot G
FAU - Gilbert, James
AU  - Gilbert J
FAU - Strony, John T
AU  - Strony JT
FAU - Califf, Robert M
AU  - Califf RM
FAU - Braunwald, Eugene
AU  - Braunwald E
CN  - EARLY ACS Steering Committee
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Peptides)
RN  - 0 (Platelet Glycoprotein GPIIb-IIIa Complex)
RN  - NA8320J834 (Eptifibatide)
SB  - IM
MH  - Acute Disease
MH  - Angina, Unstable/*drug therapy/physiopathology
MH  - Double-Blind Method
MH  - Electrocardiography
MH  - Eptifibatide
MH  - Humans
MH  - Middle Aged
MH  - Multicenter Studies as Topic
MH  - Myocardial Infarction/*drug therapy/physiopathology
MH  - Peptides/*therapeutic use
MH  - Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors
MH  - Prospective Studies
MH  - Randomized Controlled Trials as Topic/*methods
MH  - Research Design
MH  - Syndrome
MH  - Time Factors
EDAT- 2005/06/25 09:00
MHDA- 2005/12/13 09:00
CRDT- 2005/06/25 09:00
PHST- 2005/06/25 09:00 [pubmed]
PHST- 2005/12/13 09:00 [medline]
PHST- 2005/06/25 09:00 [entrez]
AID - S0002870305003261 [pii]
AID - 10.1016/j.ahj.2005.03.029 [doi]
PST - ppublish
SO  - Am Heart J. 2005 Jun;149(6):994-1002. doi: 10.1016/j.ahj.2005.03.029.