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| Sponsor: | Columbia University |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00041938 |
Purpose
The purpose of this study is to determine which of two treatments, Warfarin or aspirin, is better for preventing death and stroke in patients with poor heart function.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Disease Stroke Ischemic Heart Disease Myocardial Infarction |
Drug: aspirin Drug: Warfarin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| Official Title: | Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial |
| Estimated Enrollment: | 3201 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
aspirin
|
Drug: aspirin
325 mg per day
|
|
2: Active Comparator
warfarin
|
Drug: Warfarin
INR 2.5-3.0; target INR 2.75
|
Warfarin has proven effective in patients with ischemic heart disease, especially in the reduction of stroke, death and re-infarction following myocardial infarction, and in the reduction of stroke in atrial fibrillation. Warfarin is the most promising unstudied intervention in patients with cardiac failure. This randomized, double-blind, multi-center study will define optimal antithrombotic therapy for patients with cardiac (heart) failure and patients with low ejection fraction (EF). EF is the proportion of left ventricular volume emptied during systole. It reliably measures left ventricular systolic function.
With the rapidly increasing numbers of elderly patients with heart failure, this study has important public health implications. The study will determine which of two commonly used treatments Warfarin, an anticoagulant, or aspirin, a drug which affects platelet function is better for preventing death and stroke in patients with low ejection fraction.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| Contact: Vilma Mejia | (212) 342-6058 |
Hide Study Locations| United States, Arizona | |
| University of Arizona Health Sciences Center | Recruiting |
| Tucson, Arizona, United States | |
| Contact: Denise Bruck 520-626-1933 dbruck@email.arizona.edu | |
| Principal Investigator: Vince Sorrell | |
| Southern Arizona Veterans Affairs Medical Center | Recruiting |
| Tucson, Arizona, United States | |
| Contact: Sherry Daugherty 520-792-1450 Sherry.Daugherty@va.gov | |
| Principal Investigator: Steven Goldman | |
| United States, California | |
| Santa Clara Medical Center | Recruiting |
| Santa Clara, California, United States | |
| Contact: Patricia Lockyer 408-851-3826 patricia.lockyer@kp.org | |
| Principal Investigator: Erna Nishime | |
| West Los Angeles Veterans Affairs Medical Center | Recruiting |
| West Los Angeles, California, United States | |
| Contact: Janet Johnson 310-478-3711 Janet.Johnson8@va.gov | |
| Principal Investigator: Alberta Warner | |
| United States, Colorado | |
| Denver Veterans Affairs Medical Center | Recruiting |
| Denver, Colorado, United States | |
| Contact: Barbara Watson 303-399-8020 barbara.watson2@med.va.gov | |
| Principal Investigator: Brack Hattler | |
| Denver Health Medical Center | Recruiting |
| Denver, Colorado, United States | |
| Contact: Matthew Applegate 303-436-7431 matthew.applegate@dhha.org | |
| Principal Investigator: Richard Hughes | |
| United States, District of Columbia | |
| George Washington University | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact: Donna Embersit 202-741-2798 dembersit@mfa.gwu.edu | |
| Principal Investigator: Richard Katz, MD | |
| United States, Florida | |
| Mayo Clinic Transplant Center | Recruiting |
| Jacksonville, Florida, United States | |
| Contact: Pamela Oldano 904-956-3270 oldano.pamela@mayo.edu | |
| Principal Investigator: Daniel Yip | |
| Mercy Research Institute | Recruiting |
| Miami, Florida, United States | |
| Contact: Adriana Silva 305-854-4400 ext 2495 ASilva@mercymiami.org | |
| Principal Investigator: Javier Jimenez | |
| Cardiovascular Consultants of South Florida | Recruiting |
| Tamarac, Florida, United States | |
| Contact: Miriam Johnson 954-721-6680 mjohnson@cardiologyfl.com | |
| Principal Investigator: Ricky Schneider | |
| Melbourne Internal Medicine Associates | Recruiting |
| Melbourne, Florida, United States | |
| Contact: Carole Vasile 321-725-4500 Carole.Vasile@mima.com | |
| Principal Investigator: Bhuvaneswari Dandapani | |
| Jackson Memorial Hospital/U. of Miami | Recruiting |
| Miami, Florida, United States | |
| Contact: Maria del Carmen Lichtenberger 305-243-1386 mlichtenberger@med.miami.edu | |
| Principal Investigator: Gustavo Ortiz, MD | |
| United States, Georgia | |
| Morehouse School of Medicine | Recruiting |
| Atlanta, Georgia, United States | |
| Contact: Patricia Jackson 404-752-1067 pjackson@msm.edu | |
| Principal Investigator: Elizabeth Ofili | |
| Northeast Georgia Heart Center | Recruiting |
| Gainesville, Georgia, United States | |
| Contact: Gina Nesbit 678-989-5003 research@ngheartcenter.com | |
| Principal Investigator: Brenda Hott, MD | |
| United States, Illinois | |
| Methodist Heart, Lung and Vascular Institute | Recruiting |
| Peoria, Illinois, United States | |
| Contact: Tracy Rennie 309-672-4808 tlrennie@mmci.org | |
| Principal Investigator: Alexander Alder | |
| University of Illinois at Chicago | Recruiting |
| Chicago, Illinois, United States | |
| Contact: Karen Whited 312-996-0572 kwhited@uic.edu | |
| Principal Investigator: Thomas Stamos | |
| United States, Kentucky | |
| Louisville Veterans Affairs Medical Center | Recruiting |
| Louisville, Kentucky, United States | |
| Contact: Rita Longaker 502-587-4430 heartres@aol.com | |
| Principal Investigator: Marcus Stoddard | |
| University of Louisville | Recruiting |
| Louisville, Kentucky, United States | |
| Contact: Rita Longaker 502-587-4430 heartres@aol.com | |
| Principal Investigator: Marcus Stoddard | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States | |
| Contact: Debra Taylor 859-257-5560 DTAYL2@email.uky.edu | |
| Principal Investigator: L.Creed Pettigrew | |
| United States, Louisiana | |
| Gulf Regional Research, LLC | Recruiting |
| Metairie, Louisiana, United States | |
| Contact: Louise Roffidal 504-220-6275 tgiles4@cox.net | |
| Principal Investigator: Thomas Giles | |
| LSU Health Sciences Center | Recruiting |
| Shreveport, Louisiana, United States | |
| Contact: Pat Jinkins 318-813-1481 pjinki@lsuhsc.edu | |
| Principal Investigator: Roger Kelley | |
| United States, Massachusetts | |
| Lahey Clinic | Recruiting |
| Burlington, Massachusetts, United States | |
| Contact: Junius Beebe 781-744-5601 Junius.O.Beebe@lahey.org | |
| Principal Investigator: Matthew Tilem | |
| United States, Michigan | |
| Veterans Affairs Medical Center | Recruiting |
| Detroit, Michigan, United States | |
| Contact: Elizabeth Jones 313-576-3277 elizabeth.jones3@va.gov | |
| Principal Investigator: Preeti Ramappa | |
| Mercy Health Partners | Recruiting |
| Muskegon, Michigan, United States | |
| Contact: Kathleen Thomas 231-672-3941 thomask@trinity-health.org | |
| Principal Investigator: Mark Meengs, MD | |
| United States, Nevada | |
| Reno Veterans Affairs Medical Center | Recruiting |
| Reno, Nevada, United States | |
| Contact: Anne Baker 775-328-1830 anne.baker@med.va.gov | |
| Principal Investigator: William Graettinger | |
| United States, New Hampshire | |
| Concord Hospital | Recruiting |
| Concord, New Hampshire, United States | |
| Contact: Mary Macklin 603-227-7000 mmacklin@crhc.org | |
| Principal Investigator: Kenneth Deloge, MD | |
| United States, New Jersey | |
| University of Medicine and Dentistry of New Jersey | Recruiting |
| Newark, New Jersey, United States | |
| Contact: Tina Occhiuto 973-972-4708 occhiutm@umdnj.edu | |
| Principal Investigator: Christine Gerula | |
| UMDNJ - New Brunswick | Recruiting |
| New Brunswick, New Jersey, United States | |
| Contact: Laurie Casazza 732-235-8694 casazzla@umdnj.edu | |
| Principal Investigator: Sebastian Palmeri | |
| United States, New York | |
| University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States | |
| Contact: Vicki Conary-Rocco 585-273-4956 Vicki_Rocco@urmc.rochester.edu | |
| Principal Investigator: John Bisognano | |
| Buffalo General Hospital | Recruiting |
| Buffalo, New York, United States | |
| Contact: Mary Bonora 716-859-4641 mbonora@kaleidahealth.org | |
| Principal Investigator: Susan Graham | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States | |
| Contact: Arlene Travis 212-241-6121 Arlene.Travis@mssm.edu | |
| Principal Investigator: Bruce Darrow | |
| Columbia University, New York Presbyterian Hospital PH 3-342 | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Vilma Mejia 212-342-6058 | |
| Principal Investigator: Shunichi Homma, M.D. | |
| Kaleida Health Millard Fillmore Hospital | Recruiting |
| Buffalo, New York, United States | |
| Contact: Karol Rejman 716-887-4048 KRejman@kaleidahealth.org | |
| Principal Investigator: Michael Wilson | |
| Northport Veterans Affairs Medical Center | Recruiting |
| Northport, New York, United States | |
| Contact: Diana Mauceri 631-261-4400 dianagrace.mauceri@va.gov | |
| Principal Investigator: George Mallis | |
| Long Island Jewish Medical Center | Recruiting |
| New Hyde Park, New York, United States | |
| Contact: Rosario Gonzaga-Camfield 718-470-7367 rcamfiel@lij.edu | |
| Principal Investigator: Richard Libman | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States | |
| Contact: Andre Gabriel 212-305-9282 apg2120@columbia.edu | |
| Principal Investigator: Carlos Rodriguez, MD | |
| Five Towns Neuroscience Research | Recruiting |
| Cedarhurst, New York, United States | |
| Contact: Cheryl Casale 516-239-1800 ccasale@ftniresearch.com | |
| Principal Investigator: David Steiner | |
| Albany Medical College | Recruiting |
| Albany, New York, United States | |
| Contact: Carolyn Voulgaridis 518-262-6693 voulgaC@mail.amc.edu | |
| Principal Investigator: Edward Philbin, MD | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States | |
| Contact: Carl Schuler 919-843-4597 carl_schuler@med.unc.edu | |
| Principal Investigator: Patricia Chang | |
| United States, Ohio | |
| MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States | |
| Contact: Scott Bailey 216-778-7476 sbailey@metrohealth.org | |
| Principal Investigator: Joseph Hanna | |
| United States, Oklahoma | |
| Oklahoma City Veterans Affairs Medical Center | Recruiting |
| Oklahoma City, Oklahoma, United States | |
| Contact: John Turner 405-270-0501 john-turner@ouhsc.edu | |
| Principal Investigator: Udho Thadani | |
| United States, Pennsylvania | |
| Penn Presbyterian Medical Center | Recruiting |
| Philadelphia, Pennsylvania, United States | |
| Contact: Susanne Donovan 856-261-6605 Susanne.donovan@uphs.upenn.edu | |
| Principal Investigator: Brian Drachman | |
| Sewickley Valley Medical Group, Cardiology | Recruiting |
| Leetsdale, Pennsylvania, United States | |
| Contact: Jessica Hobbs-Williams 724-728-3302 jhobbs@hvhs.org | |
| Principal Investigator: Michael Malkowski | |
| Temple University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States | |
| Contact: Jennie Wong 215-707-5340 Jennie.Wong@tuhs.temple.edu | |
| Principal Investigator: Lazaros Nikolaidis | |
| Tri-State Medical Group Cardiology | Recruiting |
| Beaver, Pennsylvania, United States | |
| Contact: Jessica Hobbs-Williams 724-728-3302 jhobbs@hvhs.org | |
| Principal Investigator: Michael Malkowski, MD | |
| Albert Einstein Medical Center | Recruiting |
| Philadelphia, Pennsylvania, United States | |
| Contact: Rohini Bhole 215-456-3894 bholeroh@einstein.edu | |
| Principal Investigator: Jonathan Dissin | |
| Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States | |
| Contact: Kimberly Craig 215-662-6900 craigk@uphs.upenn.edu | |
| Principal Investigator: Thomas Cappola | |
| Lehigh Valley Hospital | Recruiting |
| Allentown, Pennsylvania, United States | |
| Contact: Susan Nabhan 610-402-9340 susan.nabhan@lvh.com | |
| Principal Investigator: Ronald Freudenberger | |
| United States, South Dakota | |
| Black Hills Health Care System | Recruiting |
| Fort Meade, South Dakota, United States | |
| Contact: Barbara McGinnis 605-720-7375 Barbara.McGinnis@va.gov | |
| Principal Investigator: Lana Fischer, MD | |
| United States, Texas | |
| Brooke Army Medical Center MCHE - MDC Cardiology Service | Recruiting |
| Ft. Sam Houston, Texas, United States | |
| Contact: Dorette Pearce Moore 210-916-4417 dorette.pearcemoore@amedd.army.mil | |
| Principal Investigator: Ahmad Slim | |
| Michael E. DeBakey Veterans Affairs Medical Center-MEDVAMC | Recruiting |
| Houston, Texas, United States | |
| Contact: Gilberto DeFreitas 713-794-7759 gdefreit@bcm.tmc.edu | |
| Principal Investigator: Biyhem Bozkurt | |
| United States, Virginia | |
| Salem VAMC | Recruiting |
| Salem, Virginia, United States | |
| Contact: Tracy Ochalek 540-982-2463 tracy.ochalek@med.va.gov | |
| Principal Investigator: Nabil Jarmukli | |
| United States, West Virginia | |
| Huntington Veterans Affairs Medical Center | Recruiting |
| Huntington, West Virginia, United States | |
| Contact: Sandra Shaw 304-429-6755 sandra.shaw@va.gov | |
| Principal Investigator: Joseph Pellecchia | |
| United States, Wisconsin | |
| William S. Middleton Memorial Veterans Hospital | Recruiting |
| Madison, Wisconsin, United States | |
| Contact: Lou Ellen Williams 608-256-1901 LouEllen.Williams@med.va.gov | |
| Principal Investigator: Peter Kosolcharoen | |
| Canada, Alberta | |
| Center for Neurologic Research | Recruiting |
| Lethbridge, Alberta, Canada | |
| Contact: Carolyn Walker 4033294828 c-nr@shaw.ca | |
| Principal Investigator: Toni Winder | |
| Canada, Manitoba | |
| St. Boniface General Hospital | Recruiting |
| Winnipeg, Manitoba, Canada | |
| Contact: Rachel Gerstein 2042372793 rgerstein@sbgh.mb.ca | |
| Principal Investigator: Shelley Zieroth | |
| Canada, New Brunswick | |
| Saint John Regional Hospital | Recruiting |
| Saint John, New Brunswick, Canada | |
| Contact: Ann McNulty 5066486441 mcnan@reg2.health.nb.ca | |
| Principal Investigator: Richard Bessoudo | |
| Canada, Nova Scotia | |
| QE II Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada | |
| Contact: Margo MacFarlane 902-4732728 margo.macfarlane@cdha.nshealth.ca | |
| Principal Investigator: Miroslaw Rajda | |
| Canada, Ontario | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Sandra Felix 416-864-6060 felixs@smh.toronto.on.ca | |
| Principal Investigator: Gordon Moe | |
| Ottawa Heart Institute | Recruiting |
| Ottawa, Ontario, Canada | |
| Contact: JoAnn Donaldson 6137614296 jdonaldson@ottawaheart.ca | |
| Principal Investigator: Haissam Haddad | |
| Etobicoke Cardiac Research Centre | Recruiting |
| Rexdale, Ontario, Canada | |
| Contact: Bev Donnelly 416-7478560 etobicokecardiology@bellnet.ca | |
| Principal Investigator: Toan To | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada | |
| Contact: Julie Smith 5196858500 JulieK.Smith@lhsc.on.ca | |
| Principal Investigator: Malcolm Arnold | |
| Canada, Quebec | |
| Montreal General Hospital | Recruiting |
| Montreal, Quebec, Canada | |
| Contact: Barbara St. Jacques 514-934-1934 barbara.stjacques@muhc.mcgill.ca | |
| Principal Investigator: Thao Huynh | |
| Montreal Heart Institute | Recruiting |
| Montreal, Quebec, Canada | |
| Contact: Helene Brown 5143763330 helene.brown@icm-mhi.org | |
| Principal Investigator: Anique Ducharme | |
| Principal Investigator: | Shunichi Homma, M.D. | Principal Cardiologist, Associate Chief, Division of Cardiology, and Director, Echocardiography Laboratories Professor of Medicine |
| Principal Investigator: | Seamus Thompson, PhD | Statistical PI: Clinical Professor of Biostatistics and Neurology |
More Information
| Responsible Party: | Columbia University, College of Physicians and Surgeons ( Shunichi Homma, MD ) |
| Study ID Numbers: | U01NS43975-01, U01NS39143-01, R01NS39154, CRC |
| Study First Received: | July 19, 2002 |
| Last Updated: | May 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00041938 History of Changes |
| Health Authority: | United States: Federal Government |
|
heart disease stroke ischemic heart disease myocardial infarction atrial fibrillation |
low ejection fraction cardiac failure aspirin Warfarin anticoagulant |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Hematologic Agents Physiological Effects of Drugs Fibrinolytic Agents Brain Diseases Cerebrovascular Disorders Fibrin Modulating Agents Necrosis Pathologic Processes Aspirin Sensory System Agents Therapeutic Uses Cardiovascular Diseases |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Myocardial Infarction Anticoagulants Heart Diseases Cyclooxygenase Inhibitors Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Cardiovascular Agents Ischemia Warfarin Pharmacologic Actions |