Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus: A Prospective Randomized Outcome Blinded Study on the Size Reduction or Resolution of Left Ventricular Thrombus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Percent Change in Left Ventricular Thrombus (LVT) Size
研究概览
简要总结
The purpose of this study is to compare the novel oral anticoagulant apixaban with the standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus over 3 months.
详细描述
Current treatment for left ventricular thrombus is anti-coagulant or blood thinning agent known as warfarin. Recently at least three novel oral anticoagulant agents were used in the treatment of atrial fibrillation, pulmonary embolism and deep vein thrombosis (DVT).
Novel oral anticoagulant drugs will require no blood taking for INR monitoring, hence less visit and more convenience to patients. Latest studies also showed lesser rate of bleeding as compared to warfarin and hence relatively safer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 - 80 years old
- •Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG 1996), with regional wall motion abnormalities
- •HASBLED score less than 3
- •No episodes of major bleeding in the past 6 months a) Major bleeding defined as i. episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits
排除标准
- •Patient with unstable arrhythmias and/or recurrent cardiogenic shock
- •Patient with large ischemic stroke on recruitment-defined as involving >1/3 of cerebral hemisphere or deemed to have high chance of haemorrhagic transformation
- •Patient with permanent pacemaker
- •Patient who is post valve replacement therapy
- •Patient who is pregnant.
- •Patient with advanced kidney disease at stage V and not on dialysis (CrCl <15 mL/min)
- •Patient with advanced liver disease with coagulopathy
- •Patient with organized and old left ventricular thrombus
研究组 & 干预措施
warfarin sodium
warfarin daily, dosage according to INR monitor. Aim INR 2-3
干预措施: Warfarin Sodium (Drug)
apixaban
Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.
干预措施: Apixaban 5 MG Oral Tablet [ELIQUIS] (Drug)
结局指标
主要结局
Percent Change in Left Ventricular Thrombus (LVT) Size
时间窗: 3 months
Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment
次要结局
- Life Threatening Bleeding(3 months)
- Change of Left Ventricular Thrombosis (LVT) by More Than 50%(3 months)
- Clinically Definite Cardiac Embolic Ischemic Stroke(3 months)
研究者
Dr W. Yus Haniff W. Isa
DR
Universiti Sains Malaysia