Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography
研究概览
简要总结
Left ventricular (LV) thrombus is a common problem that is encountered in patients who survived from a large myocardial infarction, and distal systemic embolization is the main issue in these patients due to its major clinical consequences especially cerebrovascular stroke.
Novel oral anticoagulants (NOACs) are now used safely in nonvalvular atrial fibrillation, these agents were shown to be at least as effective as Vitamin K antagonists (VKA) such as warfarin in prevention of systemic embolism, while having an improved safety profile with less bleeding risk. However, the data about their usage for LV thrombi instead of the commonly used VKA are still lacking except for case reports and small case series.
The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus.
详细描述
The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus.
So patients with actual LV thrombus will be divided into 2 groups, one will receive the traditional therapy which is warfarin with follow up of the INR in order to reach the desired level of 2-3 then follow up every two weeks to determine the time in therapeutic range until the end of the study follow up. The other group will receive oral rivaroxaban 20 mg per day with follow up for the persistence or the disappearance of the LV thrombus one month, three months and 6 months later.
As a secondary and safety end point, any major bleeding will be recorded as well as any thrombo-embolic events
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
- 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
- •Evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE).
排除标准
- •Creatinine clearance less than 50 ml/min.
研究组 & 干预措施
Warfarin
38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive warfarin by the regular starting dose with follow up of the INR to target (2-3)
干预措施: Warfarin Sodium (Drug)
Rivaroxaban
38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive rivaroxaban in a dose of 20 mg per day
干预措施: Rivaroxaban 20 MG (Drug)
结局指标
主要结局
Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography
时间窗: 6 months
2D transthoracic echocardiography will be done after 6 months of initiation of the anticoagulant in order to assess the presence/absence of the thrombus
次要结局
- Major bleeding(Up to 6 months)
- Stroke or systemic embolism(Up to 6 months)
研究者
Abdallah Almaghraby
Senior Registrar of Cardiology and Angiology
The Young Investigator Group of Cardiovascular Research