A Prospective Randomized Trial Comparing Enoxaparin to Warfarin for the Prevention of LV Thrombus Formation After Anterior Wall Myocardial Infarction: A 60 Patient Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- What is the incidence of LV mural thrombus with administration of enoxaparin vs.
研究概览
简要总结
To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV mural thrombus at 3.5 months. The secondary outcome is cost analysis comparing the two arms.
详细描述
Patients with anterior Q-wave MIs and ejection fractions<=40% will be enrolled within the first 4 days of infarction. Patients will be randomized to receive either enoxaparin 1mg/kg (maximum 100mg) subcutaneously every 12 hours for one month or heparin followed by oral warfarin for 3 months.
Clinical and safety evaluations, 2-D echocardiograms at baseline and at 3.5 months and cost analysis will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80
- •Anterior myocardial infarction with:
- •Pathological Q-waves in at least 3 contiguous anterior precordial leads, assumed to be new
- •CK peak>5 times the upper limit of normal with positive MB bands
- •Ejection fraction <=40% or anterior dyskinesis or documented LV Thrombus
- •MI onset < 7 days from randomization
排除标准
- •Inability to give written informed consent
- •Medical conditions that would prohibit discharge within 48 hours with the exception of need for anticoagulation
- •Cardiogenic shock, rest angina unresponsive to medical therapy or serious ventricular arrhythmia in the 24 hours prior to randomization
- •Patients scheduled for surgical procedure in the next 4 months that would prevent use of enoxaparin or warfarin
- •Anemia: Baseline Hgb<=9 gm for women, <=10 gm for men or platelet count<100,000
- •Renal insufficiency (creatinine >2.0 mg/dl)
- •Serious liver disease as reflected by INR>1.3
- •Stroke within past 6 months or a prior documented intracranial or subarachnoid hemorrhage
- •Active bleeding or major surgery within 2 weeks prohibiting the use of anticoagulants
- •Acute pericarditis
- •Women of childbearing potential unless pregnancy test negative
- •Cardiac or non-cardiac condition with expected survival< 6 months
- •Severe peripheral vascular disease
- •Patients who undergo cardiac surgery, including CABG, as a result of their index myocardial infarction
- •Allergy to aspirin, heparin or warfarin, pork or pork products
- •History of recurrent thromboembolic disease or a history of Protein C, Protein S, antithrombin III deficiency or known bleeding disorder.
- •Current use of warfarin or need for chronic anticoagulation
- •Current participation in other trials using investigational drugs or devices
- •Prior enrollment in this trial
结局指标
主要结局
What is the incidence of LV mural thrombus with administration of enoxaparin vs.
warfarin at 3.5 months in patients presenting with anterior wall myocardial
infarctions.
次要结局
- What are the associated costs and length of hospital stay after randomized to
- enoxaparin vs. warfarin?