EXCEED THE SPACE PROVIDED. WARCEF-STAT and WARCEF-CLIN are two separate but highly coordinated units which together constitute WARCEF, a two-arm (1:1) double-blind randomized multicenter clinical trial (target enrollment 2860 patients at 70 clinical sites) designed to test the primary null hypothesis of no difference between warfarin (INR 2.5-3, target 2.75) and aspirin (325 mg/day) in 3-5 year survival for the composite endpoint death or stroke or intracerebral hemorrhage among patients with low (<=30%) cardiac Left Ventricular Ejection Fraction (LVEF). Prespecified secondary hypotheses are tested for subgroups of women and African Americans, and for the endpoint of stroke alone. Prespecified tertiary hypotheses are tested by amalgamating data from WARCEF and another trial (WATCH). The goals of WARCEF-STAT are: 1) to conduct, efficiently integrate, and be responsible for all WARCEF data management, double-blinding, medication management, quality control, and reporting operations. 2) to specify, conduct and be responsible for all interim, safety, and final statistical analyses for WARCEF and for the reporting of these results. 3) to transmit to the Clinical Coordinating Center (CCC) in a timely fashion all of the data which the principal investigator of WARCEF-CLIN needs to meet his responsibilities in terms of ensuring patient safety and directing all clinical operations. Goal 1 is accomplished by integrating a Data Management Center with substantial experience in cardiac trials and an anticoagulation unit which is successfully conducting an ongoing double blind warfarin-aspirin study (WARSS). The double-blind algorithm used in WARSS to fabricate INRs for patients on active aspirin will be recalibrated and revalidated for the WARCEF target range before WARCEF begins. Goal 2 is achieved by a statistical analysis unit that is experienced in stroke, cardiac, and other clinical trials. Goal 3 is ensured by an Operations Committee of WARCEF-STAT and WARCEF-CLIN investigators and senior coordinators which meets frequently under tightly specified and controlled communication protocols.

National Institute of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Research Project--Cooperative Agreements (U01)
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Application #
Study Section
Special Emphasis Panel (ZNS1-SRB-K (01))
Program Officer
Marler, John R
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Columbia University (N.Y.)
Biostatistics & Other Math Sci
Schools of Public Health
New York
United States
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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
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
Shaffer, Jonathan A; Thompson, John L P; Cheng, Bin et al. (2014) Association of quality of life with anticoagulant control in patients with heart failure: the Warfarin and Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) trial. Int J Cardiol 177:715-7

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