Heart failure (HF) and low left ventricular (LV) ejection fraction (EF) are associated with significant risk for stroke and death. However, the value of antithrombotic / antiplatelet therapy to reduce adverse events remains controversial. Warfarin and aspirin are most often used without definitive data. Antiplatelet Trial in Chronic Heart Failure (WATCH) attempted to address this issue, but was prematurely terminated due to poor recruitment. Warfarin vs. Aspirin in Reduced Cardiac Ejection Fraction Trial (WARCEF) is designed to address this issue. The primary aim of this randomized, double-blind, multi-center clinical trial is to determine whether warfarin (INR 2.5-3.0;target INR 2.75) or aspirin (325 mg per day) is superior for preventing the combined end point of all-cause mortality and stroke (both ischemic and hemorrhagic) in patients with LV EF<35%. The primary null hypothesis is that in patients with EF80% power. Follow up period will then range from 2 to 6 years. As such, if necessary, we plan to request additional funding after this cycle to obtain appropriate power. With ending of WATCH, this study remains the only study assessing the role of anticoagulation in patients with low EF, with major implications for how the growing number of HF patients will be treated.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
4U01NS043975-10
Application #
7927676
Study Section
Special Emphasis Panel (ZNS1-SRB-K (46))
Program Officer
Moy, Claudia S
Project Start
2001-09-30
Project End
2011-08-31
Budget Start
2009-09-15
Budget End
2010-08-31
Support Year
10
Fiscal Year
2009
Total Cost
$8,158,474
Indirect Cost
Name
Columbia University (N.Y.)
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
621889815
City
New York
State
NY
Country
United States
Zip Code
10032
Di Tullio, Marco R; Qian, Min; Thompson, John L P et al. (2018) Left atrial volume and cardiovascular outcomes in systolic heart failure: effect of antithrombotic treatment. ESC Heart Fail 5:800-808
Lee, Tetz C; Qian, Min; Lip, Gregory Y H et al. (2018) Heart Failure Severity and Quality of Warfarin Anticoagulation Control (From the WARCEF Trial). Am J Cardiol 122:821-827
Teerlink, John R; Qian, Min; Bello, Natalie A et al. (2017) Aspirin Does Not Increase Heart Failure Events in Heart Failure Patients: From the WARCEF Trial. JACC Heart Fail 5:603-610
Nakanishi, Koki; Di Tullio, Marco R; Qian, Min et al. (2017) Resting Heart Rate and Ischemic Stroke in Patients with Heart Failure. Cerebrovasc Dis 44:43-50
Kato, Tomoko S; Di Tullio, Marco R; Qian, Min et al. (2016) Clinical and Echocardiographic Factors Associated With New-Onset Atrial Fibrillation in Heart Failure?- Subanalysis of the WARCEF Trial. Circ J 80:619-26
Di Tullio, Marco R; Thompson, John L P; Homma, Shunichi et al. (2016) Response by Di Tullio et al to Letter Regarding Article, ""Left Ventricular Ejection Fraction and Risk of Stroke and Cardiac Events in Heart Failure: Data From the Warfarin Versus Aspirin in Reduced Ejection Fraction Trial"". Stroke 47:e273
Ye, Siqin; Qian, Min; Zhao, Bo et al. (2016) CHA2 DS2 -VASc score and adverse outcomes in patients with heart failure with reduced ejection fraction and sinus rhythm. Eur J Heart Fail 18:1261-1266
Di Tullio, Marco R; Qian, Min; Thompson, John L P et al. (2016) Left Ventricular Ejection Fraction and Risk of Stroke and Cardiac Events in Heart Failure: Data From the Warfarin Versus Aspirin in Reduced Ejection Fraction Trial. Stroke 47:2031-7
Ye, Siqin; Cheng, Bin; Lip, Gregory Y H et al. (2015) Bleeding Risk and Antithrombotic Strategy in Patients With Sinus Rhythm and Heart Failure With Reduced Ejection Fraction Treated With Warfarin or Aspirin. Am J Cardiol 116:904-12
Homma, Shunichi; Thompson, John L P; Qian, Min et al. (2015) Quality of anticoagulation control in preventing adverse events in patients with heart failure in sinus rhythm: Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction trial substudy. Circ Heart Fail 8:504-9

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