PMID- 16500579
OWN - NLM
STAT- MEDLINE
DCOM- 20061003
LR  - 20131121
IS  - 1532-8414 (Electronic)
IS  - 1071-9164 (Linking)
VI  - 12
IP  - 1
DP  - 2006 Feb
TI  - Warfarin versus aspirin in patients with reduced cardiac ejection fraction 
      (WARCEF): rationale, objectives, and design.
PG  - 39-46
AB  - BACKGROUND: Warfarin is widely prescribed for patients with heart failure without 
      level 1 evidence, and an adequately powered randomized study is needed. METHODS 
      AND RESULTS: The Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction 
      study is a National Institutes of Health-funded, randomized, double-blind 
      clinical trial with a target enrollment of 2860 patients. It is designed to test 
      with 90% power the 2-sided primary null hypothesis of no difference between 
      warfarin (International Normalized Ratio 2.5-3) and aspirin (325 mg) in 3- to 
      5-year event-free survival for the composite endpoint of death, or stroke 
      (ischemic or hemorrhagic) among patients with cardiac ejection fraction < or =35% 
      who do not have atrial fibrillation or mechanical prosthetic heart valves. 
      Secondary analyses will compare warfarin and aspirin for reduction of all-cause 
      mortality, ischemic stroke, and myocardial infarction (MI), balanced against the 
      risk of intracerebral hemorrhage, among women and African Americans; and compare 
      warfarin and aspirin for prevention of stroke alone. Randomization is stratified 
      by site, New York Heart Association (NYHA) heart class (I vs II-IV), and stroke 
      or transient ischemic attack (TIA) within 1 year before randomization versus no 
      stroke or TIA in that period. NYHA class I patients will not exceed 20%, and the 
      study has a target of 20% (or more) patients with stroke or TIA within 12 months. 
      Randomized patients receive active warfarin plus placebo or active aspirin plus 
      placebo, double-blind. CONCLUSION: The results should help guide the selection of 
      optimum antithrombotic therapy for patients with left ventricular dysfunction.
FAU - Pullicino, Patrick
AU  - Pullicino P
AD  - Department of Neurology and Neurosciences, New Jersey Medical School, UMDNJ, 
      Newark, USA.
FAU - Thompson, John L P
AU  - Thompson JL
FAU - Barton, Bruce
AU  - Barton B
FAU - Levin, Bruce
AU  - Levin B
FAU - Graham, Susan
AU  - Graham S
FAU - Freudenberger, Ronald S
AU  - Freudenberger RS
CN  - WARCEF Investigators
LA  - eng
GR  - U-01 NS39143/NS/NINDS NIH HHS/United States
GR  - U01 NS43975/NS/NINDS NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - J Card Fail
JT  - Journal of cardiac failure
JID - 9442138
RN  - 0 (Anticoagulants)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 5Q7ZVV76EI (Warfarin)
RN  - R16CO5Y76E (Aspirin)
SB  - IM
MH  - Anticoagulants/*therapeutic use
MH  - Aspirin/*therapeutic use
MH  - Cardiac Output, Low/*drug therapy/*physiopathology
MH  - Double-Blind Method
MH  - Female
MH  - Goals
MH  - Humans
MH  - Platelet Aggregation Inhibitors/*therapeutic use
MH  - Research Design
MH  - *Stroke Volume
MH  - Warfarin/*therapeutic use
EDAT- 2006/02/28 09:00
MHDA- 2006/10/04 09:00
CRDT- 2006/02/28 09:00
PHST- 2003/06/19 00:00 [received]
PHST- 2005/07/20 00:00 [revised]
PHST- 2005/07/22 00:00 [accepted]
PHST- 2006/02/28 09:00 [pubmed]
PHST- 2006/10/04 09:00 [medline]
PHST- 2006/02/28 09:00 [entrez]
AID - S1071-9164(05)00715-3 [pii]
AID - 10.1016/j.cardfail.2005.07.007 [doi]
PST - ppublish
SO  - J Card Fail. 2006 Feb;12(1):39-46. doi: 10.1016/j.cardfail.2005.07.007.