EXCEED THE SPACE PROVIDED. Heart failure is one of the most important public health problems in cardiovascular medicine. There are 4.7 million Americans with heart failure and 400,000 new cases each year with 250,000 deaths and 75,000 strokes per year attributable to heart failure. Cardiac Ejection Fraction (EF) is a gooc index of left ventricular dysfunction and low EF (?30%) is a risk factor for stroke in patients with cardiac failure. WARCEF-CLIN and WARCEF-STAT are two separate but highly coordinated units which together constitute WARCEF, a two-arm (1:1) double blind randomized multicenter clinical tria (target enrollment 2860 patients at 70 clinical sites) designed to test the primary null hypothesis of nc difference between warfarin (INR 2.5-3) and aspirin (325 mg) in 3-5 year survival for the composite endpoint death or recurrent stroke or intracerebral hemorrhage among patients with low EF, Secondary hypotheses are to be tested for subgroups of women and African Americans, and for the endpoint of stroke alone. Patients with low EF by quantitative assessment or with a wall motion index <1 by echocardiography will be randomized to warfarin or aspirin. The dose of warfarin will be adjusted to keep the INR between 2.5 to 3 with a target INR of 2.75, using a double blind algorithm to fabricate INRs for patients on active aspirin has been used successfully in a multicenter warfarin- aspirin study (WARSS). Patients will be contacted monthly by phone and examined every four months over a mean follow up of 3 years to determine whether any endpoints have occurred. The study will define optimal antithrombotic therapy for patients with cardiac failure and patients with low EF. With the rapidly increasing numbers of elderly patients with cardiac failure, the study ha important public health implications. Our long term goals are to study antithrombotic therapy cardiac disease giving rise to stroke.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01NS043975-05
Application #
7067219
Study Section
Special Emphasis Panel (ZNS1-SRB-K (01))
Program Officer
Marler, John R
Project Start
2001-09-30
Project End
2008-02-29
Budget Start
2006-03-01
Budget End
2007-02-28
Support Year
5
Fiscal Year
2006
Total Cost
$3,755,619
Indirect Cost
Name
University of Medicine & Dentistry of NJ
Department
Neurosciences
Type
Schools of Medicine
DUNS #
623946217
City
Newark
State
NJ
Country
United States
Zip Code
07107
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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