WARCEF is expected to be clinically decisive WARCEF is the only trial directly comparing anticoagulant and antiplatelet therapies for this large population. Any of the three possible outcomes (warfarin superior; ASA superior; neither superior) will lead to an important treatment recommendation. The primary null hypothesis is that in patients with EF 35%, there is no difference between warfarin (target INR 2.75) and aspirin (325 mg/day) therapies in time to the first to occur of ischemic stroke, intracerebral hemorrhage, or death. This is tested against the alternative hypothesis of a non-zero difference between these two therapies, at = .05. Original design power of 80% to detect a 17.8% HR reduction is now ≈ 65%, given recruitment curtailment. We are also assessing the composite endpoint of ischemic stroke, intracerebral hemorrhage, myocardial infarction, heart failure hospitalization, or death as the top secondary endpoint , with power > 80%. “Warfarin may reduce mortality and both initial and recurrent ischemic stroke rates in patients with impaired LV function” and “we may be able to draw some conclusions about this issue from on-going WARCEF trial.” AHA/ASA GUIDELINE for Secondary Prevention of Stroke . June 2006 "Hopefully, the WARCEF trial will be completed and provide much needed data.” Nature Clinical Practice Cardiovascular Medicine. Nov 2006 WARCEF is a double-blind randomized multicenter clinical trial; its primary aim is to compare the efficacy of warfarin (INR 2.5-3.0) and aspirin therapies (325mg) in heart failure patients with low LVEF who are in sinus rhythm, while taking account of risk of hemorrhage. Enrollment ended on 1/31/2010 and recruited patients will be followed until 2011. As of January 31, 2010 (7.2 years since study start), 2305 patients have been randomized. Principal Investigators: Shunichi Homma, MD* and JLP Thompson, PhD † Columbia University, *College of Physicians and Surgeons and † Mailman School of Public Health, New York, NY WARCEF is funded by NIH-NINDS cooperative agreements U01 NS43975 & NS39143 Key Inclusion Criteria • Cardiac EF≤35% or a Wall Motion Index of 1.2 • Modified Rankin score 4. • Patient must be taking ACE inhibitors,(or ARBs, hydaralazine and nitrates) • Patients with Recent Stroke or TIA are eligible . • Chronic heart failure patients (NYHA I-IV) are eligible . Key Exclusion Criteria • The presence of unequivocal cardiac sources of embolism: Atrial Fibrillation Mechanical Valve Endocarditis Intracardiac Thrombus • Comorbid conditions that may limit survival to less than 5 years. Enrolled Subjects Cumulative Recruitment from 10/8/2002 to 1/31/2010 in North American (NA), Europe (EU) and Argentina (AR) Enrolled Subjects Breakdown by Countries (n=2305) Contact Information Vilma Vilma Mejia Mejia Clinical Trials Manager WARCEF Trial Division of Cardiology Department of Medicine 630 W. 168th St. Mail Code 44 New York, NY 10032 +1 (212) 305-3033 [email protected]

WARCEF Poster 2011_revised01312011

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The primary null hypothesis is that in patients with EF 35%, there is no difference between warfarin (target INR 2.75) and aspirin (325 mg/day) therapies in time to the first to occur of ischemic stroke, intracerebral hemorrhage, or death. This is tested against the alternative hypothesis of a non-zero difference between these two therapies, at = .05. Original design power of 80% to detect a 17.8% HR reduction is now ≈ 65%, given recruitment curtailment. We are also assessing the composite endpoint of ischemic stroke, intracerebral hemorrhage, myocardial infarction, heart failure hospitalization, or death as the top secondary endpoint, with power > 80%.“Warfarin may reduce mortality and both initial and recurrent ischemic stroke rates in patients with impaired LV function” and “we may be able to draw some conclusions about this issue from on-going WARCEF trial.” AHA/ASA GUIDELINE for Secondary Prevention of Stroke. June 2006

"Hopefully, the WARCEF trial will be completed and provide much needed data.” Nature Clinical Practice Cardiovascular Medicine. Nov 2006

WARCEF is a double-blind randomized multicenter clinical trial; its primary aim is to compare the efficacy of warfarin (INR 2.5-3.0) and aspirin therapies (325mg) in heart failure patients with low LVEF who are in sinus rhythm, while taking account of risk of hemorrhage. Enrollment ended on 1/31/2010 and recruited patients will be followed until 2011. As of January 31, 2010 (7.2 years since study start), 2305 patients have been randomized.

Principal Investigators: Shunichi Homma, MD* and JLP Thompson, PhD†

Columbia University, *College of Physicians and Surgeons and †Mailman School of Public Health, New York, NY

WARCEF is funded by NIH-NINDS cooperative agreements U01 NS43975 & NS39143

Key Inclusion Criteria• Cardiac EF≤35% or a Wall Motion Index of 1.2• Modified Rankin score 4.• Patient must be taking ACE inhibitors,(or ARBs, hydaralazine and nitrates)• Patients with Recent Stroke or TIA are eligible. • Chronic heart failure patients (NYHA I-IV) are eligible.

Key Exclusion Criteria• The presence of unequivocal cardiac sources of embolism: Atrial Fibrillation

Mechanical Valve Endocarditis Intracardiac Thrombus

• Comorbid conditions that may limit survival to less than 5 years.

Enrolled Subjects Cumulative Recruitment from 10/8/2002 to 1/31/2010 in North American (NA), Europe (EU) and Argentina (AR)

Enrolled Subjects Breakdown by Countries (n=2305) Contact Information

VilmaVilma MejiaMejiaClinical Trials Manager

WARCEF TrialDivision of Cardiology

Department of Medicine

630 W. 168th St.Mail Code 44

New York, NY 10032+1 (212) 305-3033

[email protected]