NCT00289042已完成4 期
The Use of Enoxaparin Compared to Unfractionated Heparin for Short Term Antithrombotic Therapy in Atrial Fibrillation Patients Undergoing TEE Guided Cardioversion: Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) II Randomized Multicenter Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- transient ischemic attack
研究概览
简要总结
SPECIFIC AIM: To test the safety and feasibility of using low molecular weight heparin (LMWH, enoxaparin sodium; Lovenox, Sanofi-Aventis) in lieu of unfractionated heparin (UFH) as antithrombotic therapy for patients in atrial fibrillation undergoing transesophageal echocardiography (TEE) guided chemical or electrical cardioversion to sinus rhythm.
HYPOTHESIS: Early cardioversion from atrial fibrillation can be safely performed using a short-term anticoagulation strategy of low molecular weight heparin (Lovenox, Sanofi-Aventis) compared to unfractionated heparin, accompanied by a TEE examination prior to cardioversion. The use of LMWH with TEE will result in a safe, cost-effective, and possible efficacious approach to cardioversion of atrial fibrillation compared to UFH with TEE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic or paroxysmal atrial fibrillation of > 2 days duration who are candidates for early chemical or electrical cardioversion
- •Patients with atrial flutter with a documented history (electrocardiography) of atrial fibrillation
- •Males and females 18 years of age or older
- •Patients have available results of routine clinical labs for standard clinical chemistry and complete blood count within the previous 14 days
排除标准
- •An INR > 1.4 in patients who have received warfarin prior to enrollment.
- •Use of IV heparin for more than 72 hours immediately prior to randomization.
- •Patients with contraindications to TEE, such as dysphagia, or esophageal strictures.
- •Patients who will need anticoagulation discontinued because of elective intervening procedure, such as cardiac catheterization or surgery.
- •Patients with contraindications to warfarin or heparin
- •Patients who require concomitant therapy during the study period with any drug known to affect coagulation or platelet function (i.e. ASA, NSAID, antiplatelet drugs)
- •Women of childbearing potential, unless pregnancy can be excluded by medical history incompatible with pregnancy or by serum or urine beta HCG levels.
- •Patients who are hemodynamically unstable and thus may require immediate cardioversion.
- •Weight less than 40 kg (88 pounds) or more than 125 kg (275 pounds)
- •History of gastrointestinal bleeding disorder and/or endoscopically verified ulcer disease within the last year
- •History of intracranial or retinal bleeding, or other known disorders with an increased risk of bleeding
- •Ischemic stroke in the previous three months
- •Uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 100 mm Hg)
- •Malignancy currently under active treatment, including melanoma
- •Patients with renal insufficiency (creatinine > 2.0 mg/dL) or are renal transplant subjects
- •Patients with anemia (Hgb less than 10 gm/dL)
- •Patients with thrombocytopenia (platelet count less than 100 x 10^9/L)
- •Positive fecal hemoglobin test
- •Life expectancy of less than 6 months
- •History of drug and/or alcohol abuse within the last two years
- •Patients unable or unwilling to give informed consent
- •Patients unable or unwilling to return for follow-up
- •Prisoners or wards of the state
- •Patients with psychological problems that may decrease compliance with the protocol
- •Not willing to complete the Quality of Life Questionnaires x 3
- •Participating in another clinical trial and/or taking an investigational medication in the past 30 days
- •Patient language, learning skills, or home environment unconducive to self-management
结局指标
主要结局
transient ischemic attack
peripheral embolism
major or minor bleeding
death
length of stay (LOS)
return to normal sinus rhythm (NSR)
ischemic stroke
次要结局
- quality of life
- cost-effectiveness
研究者
研究点 (2)
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