EUCTR2004-002181-38-HU进行中（未招募）1 期
Warfarin versus Aspirin in Reduced Ejection Fraction. - WARCEF
IH-National Institut of Health - NINDS-National Institut of Neurogical Disorders and Stroke0 个研究点目标入组 2,860 人开始时间: 2004年8月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,860
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Cardiac EF?35% by radionuclide ventriculography, left ventriculography or quantitative 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](http://www.ntsearch.com/search.php?q=time&v=56) of the qualifying echocardiogram. The qualifying left ventricular function measurement must be obtained at least 3 months after an MI, coronary artery bypass grafting, PTCA, and at least one month after pacemaker insertion. Patients scheduled for mitral valve repair should have qualifying echo after surgery.
- •2. Modified Rankin score ?4.
- •3. Patient must be taking ACE inhibitors. If intolerant of ACE inhibitor patient must be on angiotensin II receptor blockers or hydralazine and nitrates.
- •4. 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](http://www.ntsearch.com/search.php?q=telephone&v=56).
- •5. Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.
- •6. Patients with recent stroke or TIA within twelve (12) months will be eligible to be included in the RS (recent stroke) subgroup.
- •7. 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](http://www.ntsearch.com/search.php?q=time&v=56) of discharge. Stable New York Heart Association Class IV patients will be eligible for randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. 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.
- •2. Cyanotic congenital heart disease, Eisenmenger’s syndrome.
- •3. Decompensated heart failure.
- •4. Cardiac surgery, angioplasty, or MI within the past 3 months.
- •5. 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 warfarinuncontrolled 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](http://www.ntsearch.com/search.php?q=test&v=56) done within 30 days prior to randomization)
- •6. Patient needs continuing therapy with intravenous heparin, low molecular weight heparin or a specific antiplatelet agent.
- •7. Dementia or psychiatric or physical problem that prevents the patient from following an outpatient program reliably.
- •8. Comorbid conditions that may limit survival to less than five years.
- •9. [Pregnancy](http://www.ntsearch.com/search.php?q=Pregnancy&v=56), or female in age of childbearing potential who is not sterilized or is not using a medically accepted form of contraception* (see procedure manual).
- •10. Enrollment in another study that would conflict with the current study.
- •11. Hospitalization for new diagnosis of onset of CHF within past one month or carotid endarterectomy or pacemaker insertion within the past month.
- •12. Children under the age of 18 years. *A [pregnancy](http://www.ntsearch.com/search.php?q=pregnancy&v=56) [test](http://www.ntsearch.com/search.php?q=test&v=56) is required for all women of childbearing age.
研究者
相似试验
进行中（未招募）
不适用
Warfarin versus Aspirin in Reduced Ejection Fraction. - WARCEFPatients with left ventricular disfunction with ejection fraction less or equal to 35%.MedDRA version: 9.1Level: LLTClassification code 10019279Term: Heart failureEUCTR2004-002181-38-GBColumbia University Medical Center of New York3,201
进行中（未招募）
1 期
WARFARIN VERSUS ASPIRIN IN REDUCED CARDIAC EJECTION FRACTION (WARCEF)EUCTR2004-002181-38-SKWarcef Clinical Coordinating Center, Department of Neuroscience, University of Medicine and Dentistr2,860
已完成
3 期
Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) TrialHeart DiseaseIschemic Heart DiseaseStrokeMyocardial InfarctionNCT00041938Columbia University2,305
已完成
1 期
Treatment of High Risk Patent Foramen Ovale According to Contrast-trans Cranial Doppler Sonographypermanent or transient cerebral or retinal ischemic attack.Transient Cerebral Ischaemic attacks and related syndromes-Vascular syndromes of Brain in Cerebrovascular DiseasesG45-G46IRCT138805192323N1Shiraz University of Medical Sciences35
尚未招募
不适用
Comparison of Efficacy and Safety between Warfarin, Rivaroxaban and Edoxaban in patients with acute pulmonary embolism in showa universityJPRN-UMIN000020069Division of Cardiology, Department of Medicine,Showa university100