Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial (WARCEF)
29. August 2014 aktualisiert von: Shunichi Homma, Columbia University
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.
We are now transitioning into the sub-analysis part of the WARCEF patient data.
The study has recently completed data analysis for its Primary Aim. All randomized patients have completed their follow up. All study related procedure as per the protocol has been completed. We are now in the extension phase of the study to obtain more patient data to address further aims of the study. No new procedures are performed and data already in place at the sites will be collected (EKG and echocardiograms).
The aims for this study extension are:
- To assess progression of cardiac dysfunction over time among heart failure patients
- To correlate prognosis with cardiac dysfunction
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
2305
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Alberta
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Lethbridge, Alberta, Kanada
- Center for Neurologic Research
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Manitoba
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Winnipeg, Manitoba, Kanada
- St. Boniface General Hospital
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New Brunswick
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Saint John, New Brunswick, Kanada
- Saint John Regional Hospital
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Nova Scotia
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Halifax, Nova Scotia, Kanada
- QE II Health Sciences Centre
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Ontario
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London, Ontario, Kanada
- London Health Sciences Centre
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Ottawa, Ontario, Kanada
- Ottawa Heart Institute
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Rexdale, Ontario, Kanada
- Etobicoke Cardiac Research Centre
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Toronto, Ontario, Kanada
- St. Michael's Hospital
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Quebec
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Montreal, Quebec, Kanada
- Montreal Heart Institute
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Montreal, Quebec, Kanada
- Montreal General Hospital
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Arizona
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Tucson, Arizona, Vereinigte Staaten
- University of Arizona Health Sciences Center
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Tucson, Arizona, Vereinigte Staaten
- Southern Arizona Veterans Affairs Medical Center
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California
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Santa Clara, California, Vereinigte Staaten
- Santa Clara Medical Center
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West Los Angeles, California, Vereinigte Staaten
- West Los Angeles Veterans Affairs Medical Center
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Colorado
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Denver, Colorado, Vereinigte Staaten
- Denver Health Medical Center
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Denver, Colorado, Vereinigte Staaten
- Denver Veterans Affairs Medical Center
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20037
- George Washington University
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Florida
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Jacksonville, Florida, Vereinigte Staaten
- Mayo Clinic Transplant Center
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Melbourne, Florida, Vereinigte Staaten
- Melbourne Internal Medicine Associates
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Miami, Florida, Vereinigte Staaten
- Jackson Memorial Hospital/U. of Miami
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Miami, Florida, Vereinigte Staaten
- Mercy Research Institute
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Tamarac, Florida, Vereinigte Staaten
- Cardiovascular Consultants of South Florida
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Georgia
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Atlanta, Georgia, Vereinigte Staaten
- Morehouse School of Medicine
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Gainesville, Georgia, Vereinigte Staaten
- Northeast Georgia Heart Center
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Illinois
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Chicago, Illinois, Vereinigte Staaten
- University of Illinois at Chicago
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Peoria, Illinois, Vereinigte Staaten
- Methodist Heart, Lung and Vascular Institute
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten
- University of Kentucky
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Louisville, Kentucky, Vereinigte Staaten
- University of Louisville
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Louisville, Kentucky, Vereinigte Staaten
- Louisville Veterans Affairs Medical Center
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Louisiana
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Metairie, Louisiana, Vereinigte Staaten
- Gulf Regional Research, LLC
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Shreveport, Louisiana, Vereinigte Staaten
- LSU Health Sciences Center
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Massachusetts
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Burlington, Massachusetts, Vereinigte Staaten
- Lahey Clinic
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Michigan
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Detroit, Michigan, Vereinigte Staaten
- Veterans Affairs Medical Center
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Muskegon, Michigan, Vereinigte Staaten
- Mercy Health Partners
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Nevada
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Reno, Nevada, Vereinigte Staaten
- Reno Veterans Affairs Medical Center
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New Hampshire
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Concord, New Hampshire, Vereinigte Staaten
- Concord Hospital
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New Jersey
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New Brunswick, New Jersey, Vereinigte Staaten
- UMDNJ - New Brunswick
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Newark, New Jersey, Vereinigte Staaten
- University of Medicine and Dentistry of New Jersey
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New York
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Albany, New York, Vereinigte Staaten
- Albany Medical College
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Buffalo, New York, Vereinigte Staaten
- Buffalo General Hospital
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Buffalo, New York, Vereinigte Staaten
- Kaleida Health Millard Fillmore Hospital
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Cedarhurst, New York, Vereinigte Staaten
- Five Towns Neuroscience Research
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New Hyde Park, New York, Vereinigte Staaten
- Long Island Jewish Medical Center
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New York, New York, Vereinigte Staaten
- Columbia University Medical Center
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New York, New York, Vereinigte Staaten
- Mount Sinai Medical Center
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New York, New York, Vereinigte Staaten, 10032
- Columbia University, New York Presbyterian Hospital PH 3-342
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Northport, New York, Vereinigte Staaten
- Northport Veterans Affairs Medical Center
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Rochester, New York, Vereinigte Staaten
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten
- University of North Carolina at Chapel Hill
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Ohio
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Cleveland, Ohio, Vereinigte Staaten
- MetroHealth Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten
- Oklahoma City Veterans Affairs Medical Center
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Pennsylvania
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Allentown, Pennsylvania, Vereinigte Staaten
- LeHigh Valley Hospital
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Beaver, Pennsylvania, Vereinigte Staaten
- Tri-State Medical Group Cardiology
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Leetsdale, Pennsylvania, Vereinigte Staaten
- Sewickley Valley Medical Group, Cardiology
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Philadelphia, Pennsylvania, Vereinigte Staaten
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten
- Temple University Hospital
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Philadelphia, Pennsylvania, Vereinigte Staaten
- Albert Einstein Medical Center
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Philadelphia, Pennsylvania, Vereinigte Staaten
- Penn Presbyterian Medical Center
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South Dakota
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Fort Meade, South Dakota, Vereinigte Staaten
- Black Hills Health Care System
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Texas
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Ft. Sam Houston, Texas, Vereinigte Staaten
- Brooke Army Medical Center MCHE - MDC Cardiology Service
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Houston, Texas, Vereinigte Staaten
- Michael E. DeBakey Veterans Affairs Medical Center-MEDVAMC
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Virginia
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Salem, Virginia, Vereinigte Staaten
- Salem Vamc
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West Virginia
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Huntington, West Virginia, Vereinigte Staaten
- Huntington Veterans Affairs Medical Center
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Wisconsin
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Madison, Wisconsin, Vereinigte Staaten
- William S. Middleton Memorial Veterans Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria
- Cardiac EF <=35% by radionuclide ventriculography, left ventriculography or quantitive echocardiographic measurement or an echocardiographic Wall Motion Index of <=1.2, within three months of enrollment. The patient's clinical cardiac state at enrollment should be similar to their state at the time of the qualifying echocardiogram. The qualifying left ventricular function measurement must be obtained at least three months after an MI, coronary bypass grafting, PTCA, and at least one month after pacemaker insertion. Patients scheduled for mitral valve repair should have qualifying echo after surgery.
- Modified Rankin score <=4.
- Patient must be taking ACE inhibitors. If intolerant of ACE inhibitor, patient must be on angiotensin II receptor blockers or hydralazine and nitrates.
- Patient is able to follow an outpatient protocol (requiring monthly blood tests and clinic visits every four months for the duration of the study) and is available by telephone.
- Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.
- Patients with recent stroke or TIA within twelve (12) months will be eligible to be included in the recent stroke (RS) subgroup.
- Chronic CHF patients (NYHA I * IV) admitted to the hospital can be randomized prior to discharge if the patient is stable, taking oral medications for 24 hours and ambulatory at the time of discharge. Stable New York Heart Association Class IV patients will be eligible for randomization.
Exclusion Criteria
- The presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal AF, mechanical valve, endocarditis, intracardiac mobile or pedunculated thrombus, and valvular vegetation.
- Cyanotic congenital heart disease, Eisenmenger's syndrome.
- Decompensated heart failure.
- Cardiac surgery, angioplasty, or MI within the past 3 months prior to randomization.
- A contraindication to the use of either warfarin or aspirin, e.g. active peptic ulcer disease, active bleeding diathesis, platelets <100,000*, hematocrit <30, INR >1.3 (if not on warfarin), clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (AST >3x normal*, cirrhosis), any condition requiring regular use of non-steroidal anti-inflammatory agents, allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure >180 mm Hg or diastolic pressure > 110 mm Hg), positive stool guaiac not attributable to hemorrhoids, creatinine >3.0*. *on most recent test done within 30 days prior to randomization
- Patient needs continuing therapy with intravenous heparin or low molecular weight heparin or a specific antiplatelet agent.
- Dementia or psychiatric or physical problem that prevents the patient from following an outpatient program reliably.
- Comorbid conditions that may limit survival to less than five years.
- Pregnancy, or female of childbearing potential who is not sterilized or is not using a medically accepted form of contraception* (see procedure manual). *A pregnancy test is required for all women of childbearing age.
- Enrollment in another study that would conflict with WARCEF.
- Hospitalization for new diagnosis of onset CHF within the past one month or carotid endarterectomy or pacemaker insertion within the past one month prior to randomization .
- Person under 18 years of age.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: aspirin
Aspirin: 325 mg per day
|
325 mg per day
|
|
Aktiver Komparator: warfarin
Warfarin: International Normalized Ratio (INR) 2.5-3.0;
target INR 2.75
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INR 2.5-3.0; target INR 2.75
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death
Zeitfenster: From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years
|
The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.
Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
|
From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.
Zeitfenster: From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.
|
The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years. Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25. |
From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Event Rate Per 100 Patient-years for Ischemic Stroke
Zeitfenster: From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years
|
Time, in years, from date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years.
Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
|
From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years
|
|
Event Rate Per 100 Patient-years for Intracerebral Hemorrhage
Zeitfenster: From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years
|
Time, in years, from date of randomization to date of intracerebral hemorrhage component of primary composite outcome.
Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
|
From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years
|
|
Event Rate Per 100 Patient-years for Death
Zeitfenster: From date of randomization to date of death component of primary composite outcome, up to 6 years
|
Time, in years, from date of randomization to date of death component of primary composite outcome.
Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
|
From date of randomization to date of death component of primary composite outcome, up to 6 years
|
|
Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome
Zeitfenster: From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years
|
Time, in years, from date of randomization to date of myocardial infarction, up to 6 years.
Includes only myocardial infarctions that occurred during follow-up, before any heart failure hospitalization.
Event rate per 100 patient years = 100*(number of subjects with myocardial infarction)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
|
From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years
|
|
Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.
Zeitfenster: From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years
|
Time, in years, from date of randomization to date of heart failure hospitalization, up to 6 years.
Includes hospitalizations for heart failure during follow-up that were not preceded by myocardial infarction.
Event rate per 100 patient years = 100*(number of subjects with heart failure hospitalization)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
|
From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years
|
|
Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome
Zeitfenster: From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years
|
Ischemic stroke component of secondary composite endpoint.
Includes only ischemic strokes that were not preceded by a myocardial infarction or heart failure hospitalization.
The number of ischemic strokes that are components of the secondary outcome does not therefore match the number of ischemic strokes that are components of the primary outcome.
Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.
|
From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years
|
|
Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome
Zeitfenster: From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years
|
Time, in years, from date of randomization to date of intracerebral hemorrhage component of secondary composite outcome.
Includes only intracerebral hemorrhages not preceded by myocardial infarction or heart failure hospitalization.
Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
|
From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years
|
|
Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome
Zeitfenster: From date of randomization to date of death component of secondary composite outcome, up to 6 years
|
Time, in years, from randomization to death component of secondary composite outcome.
This measure counts only deaths that were not preceded by heart failure hospitalization, myocardial infarction, ischemic stroke, or intracerebral hemorrhage.
Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
|
From date of randomization to date of death component of secondary composite outcome, up to 6 years
|
|
Rate Per 100 Patient Years of Major Hemorrhage
Zeitfenster: From date of randomization until end of scheduled follow-up, up to 6 years
|
Rate/100 patient-years of major hemorrhage.
Includes all major hemorrhages in any patient.
Major hemorrhage was defined as intracerebral, epidural, subdural, subarachnoid, spinal intramedullary, or retinal hemorrhage; any other bleeding causing a decline in the hemoglobin level of more than 2 g per deciliter in 48 hours; or bleeding requiring transfusion of 2 or more units of whole blood, hospitalization, or surgical intervention.
Event rate per 100 patient years = 100*(number of major hemorrhage events)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.
|
From date of randomization until end of scheduled follow-up, up to 6 years
|
|
Rate Per 100 Patient-years of Minor Hemorrhage.
Zeitfenster: From date of randomization until the end of scheduled follow-up, up to 6 years
|
Rate per 100 patient years of minor hemorrhage.
Includes all minor hemorrhages.
Minor hemorrhage was defined as any non-major hemorrhage.
Event rate per 100 patient years = 100*(number of minor hemorrhage events)/patient-years of follow-up.
Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.
|
From date of randomization until the end of scheduled follow-up, up to 6 years
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Shunichi Homma, M.D., Principal Cardiologist, Associate Chief, Division of Cardiology, and Director, Echocardiography Laboratories Professor of Medicine
- Hauptermittler: Seamus Thompson, PhD, Statistical PI: Clinical Professor of Biostatistics and Neurology
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Lee TC, Qian M, Liu Y, Graham S, Mann DL, Nakanishi K, Teerlink JR, Lip GYH, Freudenberger RS, Sacco RL, Mohr JP, Labovitz AJ, Ponikowski P, Lok DJ, Matsumoto K, Estol C, Anker SD, Pullicino PM, Buchsbaum R, Levin B, Thompson JLP, Homma S, Di Tullio MR; WARCEF Investigators. Cognitive Decline Over Time in Patients With Systolic Heart Failure: Insights From WARCEF. JACC Heart Fail. 2019 Dec;7(12):1042-1053. doi: 10.1016/j.jchf.2019.09.003.
- Teerlink JR, Qian M, Bello NA, Freudenberger RS, Levin B, Di Tullio MR, Graham S, Mann DL, Sacco RL, Mohr JP, Lip GYH, Labovitz AJ, Lee SC, Ponikowski P, Lok DJ, Anker SD, Thompson JLP, Homma S; WARCEF Investigators. Aspirin Does Not Increase Heart Failure Events in Heart Failure Patients: From the WARCEF Trial. JACC Heart Fail. 2017 Aug;5(8):603-610. doi: 10.1016/j.jchf.2017.04.011.
- Di Tullio MR, Qian M, Thompson JL, Labovitz AJ, Mann DL, Sacco RL, Pullicino PM, Freudenberger RS, Teerlink JR, Graham S, Lip GY, Levin B, Mohr JP, Buchsbaum R, Estol CJ, Lok DJ, Ponikowski P, Anker SD, Homma S; WARCEF Investigators. 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. 2016 Aug;47(8):2031-7. doi: 10.1161/STROKEAHA.116.013679. Epub 2016 Jun 28.
- Freudenberger RS, Cheng B, Mann DL, Thompson JL, Sacco RL, Buchsbaum R, Sanford A, Pullicino PM, Levin B, Teerlink JR, Graham S, Mohr JP, Labovitz AJ, Di Tullio MR, Lip GY, Estol CJ, Lok DJ, Ponikowski P, Anker SD, Homma S; WARCEF Investigators. The first prognostic model for stroke and death in patients with systolic heart failure. J Cardiol. 2016 Aug;68(2):100-3. doi: 10.1016/j.jjcc.2015.09.014. Epub 2015 Nov 6.
- Homma S, Thompson JL, Qian M, Ye S, Di Tullio MR, Lip GY, Mann DL, Sacco RL, Levin B, Pullicino PM, Freudenberger RS, Teerlink JR, Graham S, Mohr JP, Labovitz AJ, Buchsbaum R, Estol CJ, Lok DJ, Ponikowski P, Anker SD; WARCEF Investigators. 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. 2015 May;8(3):504-9. doi: 10.1161/CIRCHEARTFAILURE.114.001725. Epub 2015 Apr 7.
- Shaffer JA, Thompson JL, Cheng B, Ye S, Lip GY, Mann DL, Sacco RL, Pullicino PM, Freudenberger RS, Graham S, Mohr JP, Labovitz AJ, Estol CJ, Lok DJ, Ponikowski P, Anker SD, Di Tullio MR, Homma S; WARCEF Investigators. 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. 2014 Dec 15;177(2):715-7. doi: 10.1016/j.ijcard.2014.10.012. No abstract available.
- Homma S, Thompson JL, Sanford AR, Mann DL, Sacco RL, Levin B, Pullicino PM, Freudenberger RS, Teerlink JR, Graham S, Mohr JP, Massie BM, Labovitz AJ, Di Tullio MR, Gabriel AP, Lip GY, Estol CJ, Lok DJ, Ponikowski P, Anker SD; WARCEF Investigators. Benefit of warfarin compared with aspirin in patients with heart failure in sinus rhythm: a subgroup analysis of WARCEF, a randomized controlled trial. Circ Heart Fail. 2013 Sep 1;6(5):988-97. doi: 10.1161/CIRCHEARTFAILURE.113.000372. Epub 2013 Jul 23.
- Homma S, Thompson JL, Pullicino PM, Levin B, Freudenberger RS, Teerlink JR, Ammon SE, Graham S, Sacco RL, Mann DL, Mohr JP, Massie BM, Labovitz AJ, Anker SD, Lok DJ, Ponikowski P, Estol CJ, Lip GY, Di Tullio MR, Sanford AR, Mejia V, Gabriel AP, del Valle ML, Buchsbaum R; WARCEF Investigators. Warfarin and aspirin in patients with heart failure and sinus rhythm. N Engl J Med. 2012 May 17;366(20):1859-69. doi: 10.1056/NEJMoa1202299. Epub 2012 May 2.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2002
Primärer Abschluss (Tatsächlich)
1. August 2011
Studienabschluss (Tatsächlich)
1. Juli 2014
Studienanmeldedaten
Zuerst eingereicht
19. Juli 2002
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Juli 2002
Zuerst gepostet (Schätzen)
22. Juli 2002
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
5. September 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. August 2014
Zuletzt verifiziert
1. August 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Ischämie
- Pathologische Prozesse
- Nekrose
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Arteriosklerose
- Arterielle Verschlusskrankheiten
- Koronare Krankheit
- Herzinfarkt
- Infarkt
- Herzkrankheiten
- Koronare Herzkrankheit
- Myokardischämie
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Agenten des peripheren Nervensystems
- Enzym-Inhibitoren
- Analgetika
- Agenten des sensorischen Systems
- Entzündungshemmende Mittel, nichtsteroidal
- Analgetika, nicht narkotisch
- Entzündungshemmende Mittel
- Antirheumatika
- Fibrinolytische Mittel
- Fibrinmodulierende Mittel
- Thrombozytenaggregationshemmer
- Cyclooxygenase-Inhibitoren
- Antipyretika
- Antikoagulanzien
- Aspirin
- Warfarin
Andere Studien-ID-Nummern
- AAAC1093
- CRC (NINDS)
- U01NS039143-01 (US NIH Stipendium/Vertrag)
- R01NS39154
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