Warfarin vs Aspirin in Reduced Ejection Fraction-CLIN
Warfarin vs Aspirin in Reduced Ejection Fraction-CLIN
批准号:
7405642
负责人:
Shunichi Homma
金额:
$194.66万
依托单位国家:
美国
项目类别:
财政年份:
2001
资助国家:
美国
项目状态:
已结题
起止时间:
2001-09-30 至 2007-09-20
关键词:
AddressAfrican AmericanAlgorithmsAmericanAspirinAtrial FibrillationCardiacCardiovascular systemCerebral hemisphere hemorrhageCerebrumCessation of lifeChronicClassClinicalDataDoseDouble-Blind MethodEFRACEchocardiographyEnd PointEnrollmentEquilibriumEtiologyFunctional disorderGoalsHeart DiseasesHeart failureInfarctionInternational Normalized RatioInterventionIschemic StrokeLeftLeft Ventricular DysfunctionLinkMedicineMotionMyocardial IschemiaNumbersPatientsPublic HealthRandomizedRateRecurrenceRelative (related person)Relative RisksResearchResearch PersonnelRiskRisk FactorsRisk ReductionSample SizeSideStrokeSubgroupTelephoneTestingTimeUpper armVentricularWarfarinWomanclinical research sitecognitive functiondaydesignfollow-uphazardindexingmenmortalityolder patientprevent
中文摘要
心力衰竭是心血管医学中最重要的公共卫生问题之一。那里
每年有470万美国人患有心力衰竭,
每年有75,000人死于心力衰竭心脏射血分数(EF)是一种良好的
左心室功能不全指数和低EF(<$30%)是脑卒中患者的危险因素,
心力衰竭WARCEF-CLIN和WARCEF-STAT是两个独立但高度协调的单位
这两项研究共同组成了WARCEF,一项双臂(1:1)双盲随机多中心临床试验,
(目标入组70家临床试验机构的2860例患者),旨在检验NC的主要零假设
华法林(INR 2.5-3)和阿司匹林(325 mg)在复合终点3-5年生存率方面的差异
低EF患者的终点死亡或复发性卒中或脑出血,
次要假设将在妇女和非裔美国人的亚组中进行检验,
单独的中风终点。定量评估的低EF患者或具有室壁运动指数的患者
超声心动图检查<1的患者将随机接受华法林或阿司匹林治疗。华法林的剂量为
调整以保持INR在2.5至3之间,目标INR为2.75,使用双盲算法,
为服用活性阿司匹林的患者制造INR已成功用于多中心华法林治疗,
阿司匹林研究(WARSS)每月通过电话联系患者,每四个月检查一次
平均随访3年,以确定是否发生任何终点。的
研究将确定心力衰竭患者和低血压患者的最佳抗血栓治疗。
EF.随着老年心力衰竭患者数量的迅速增加,该研究具有重要意义。
重要的公共卫生影响。我们的长期目标是研究抗血栓治疗
引起中风的心脏病。
英文摘要
Heart failure is one of the most important public health problems in cardiovascular medicine. There
are 4.7 million Americans with heart failure and 400,000 new cases each year with 250,000 deaths
and 75,000 strokes per year attributable to heart failure. Cardiac Ejection Fraction (EF) is a gooc
index of left ventricular dysfunction and low EF (¿30%) is a risk factor for stroke in patients with
cardiac failure. WARCEF-CLIN and WARCEF-STAT are two separate but highly coordinated units
which together constitute WARCEF, a two-arm (1:1) double blind randomized multicenter clinical tria
(target enrollment 2860 patients at 70 clinical sites) designed to test the primary null hypothesis of nc
difference between warfarin (INR 2.5-3) and aspirin (325 mg) in 3-5 year survival for the composite
endpoint death or recurrent stroke or intracerebral hemorrhage among patients with low EF,
Secondary hypotheses are to be tested for subgroups of women and African Americans, and for the
endpoint of stroke alone. Patients with low EF by quantitative assessment or with a wall motion index
<1 by echocardiography will be randomized to warfarin or aspirin. The dose of warfarin will be
adjusted to keep the INR between 2.5 to 3 with a target INR of 2.75, using a double blind algorithm to
fabricate INRs for patients on active aspirin has been used successfully in a multicenter warfarin-
aspirin study (WARSS). Patients will be contacted monthly by phone and examined every four
months over a mean follow up of 3 years to determine whether any endpoints have occurred. The
study will define optimal antithrombotic therapy for patients with cardiac failure and patients with low
EF. With the rapidly increasing numbers of elderly patients with cardiac failure, the study ha
important public health implications. Our long term goals are to study antithrombotic therapy
cardiac disease giving rise to stroke.
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Warfarin vs. Aspirin in Reduced Ejection Fraction (WARCEF)
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批准号:7499026
-
项目类别:
-
资助金额:$678.19万
-
财政年份:2001
-
负责人:Shunichi Homma
-
依托单位:
Warfarin vs. Aspirin in Reduced Ejection Fraction (WARCEF)
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批准号:7927676
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项目类别:
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资助金额:$815.85万
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财政年份:2001
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负责人:Shunichi Homma
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依托单位:
RIGHT VENTRICULAR FUNCTION WITH MUGA, MRI, 3D ULTRASOUND
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批准号:6567814
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项目类别:
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资助金额:$19.29万
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财政年份:2001
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负责人:Shunichi Homma
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依托单位:
Warfarin vs. Aspirin in Reduced Ejection Fraction (WARCEF)
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批准号:7929486
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项目类别:
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资助金额:$200.0万
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负责人:Shunichi Homma
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依托单位:
Warfarin vs. Aspirin in Reduced Ejection Fraction (WARCEF)
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批准号:7315307
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项目类别:
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资助金额:$567.42万
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财政年份:2001
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负责人:Shunichi Homma
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依托单位:
RIGHT VENTRICULAR FUNCTION WITH MUGA, MRI, 3D ULTRASOUND
-
批准号:6468552
-
项目类别:
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资助金额:$19.29万
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财政年份:2000
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负责人:Shunichi Homma
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依托单位:
PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE
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批准号:6015487
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项目类别:
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资助金额:$7.77万
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财政年份:1999
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负责人:Shunichi Homma
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依托单位:
PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE
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批准号:6139506
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项目类别:
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资助金额:$19.45万
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财政年份:1994
-
负责人:Shunichi Homma
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依托单位:
PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE
-
批准号:2858157
-
项目类别:
-
资助金额:$19.25万
-
财政年份:1994
-
负责人:Shunichi Homma
-
依托单位:
PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE
-
批准号:2270786
-
项目类别:
-
资助金额:$20.53万
-
财政年份:1994
-
负责人:Shunichi Homma
-
依托单位:
PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE
-
批准号:2270785
-
项目类别:
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资助金额:$41.08万
-
财政年份:1994
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负责人:Shunichi Homma
-
依托单位:
PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE
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批准号:2504333
-
项目类别:
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资助金额:$9.65万
-
财政年份:1994
-
负责人:Shunichi Homma
-
依托单位:
PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE
-
批准号:2037754
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项目类别:
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资助金额:$22.5万
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财政年份:1994
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负责人:Shunichi Homma
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依托单位:
PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE
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批准号:2445807
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项目类别:
-
资助金额:$9.22万
-
财政年份:1994
-
负责人:Shunichi Homma
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依托单位:
海外基金