Comparison of Different Anticoagulation Regiments in Patients With Prosthetic Heart Valve Non-ObstructiveThrombosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Increased thrombus size
研究概览
简要总结
Prosthetic valve thrombosis is a serious complication with high mortality and morbidity. However, the best anticoagulant treatment strategies for patients with prosthetic heart valve thrombosis have not been fully known. In this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.
详细描述
Three different anticoagulant treatment regimens for patients with prosthetic heart valve non-obstructive thrombosis have been described. Patients are included in each group randomly. In the first arm only warfarin is given to the patients with a target INR level of 2.5-4. In the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin. In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in ombination with warfarin. Also there is an observational follow-up group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4 . All patients are followed by serial transesophageal echocardiography performed every 6 months. Follow-up period is at least 6 months (range 6-60 months). Informed consent is taken from all patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with prosthetic heart valve thrombosis
排除标准
- 未提供
研究组 & 干预措施
Warfarin
In the first arm only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis
干预措施: Warfarin (Drug)
Warfarin + ASA 100 mg + PPI
In the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis
干预措施: Warfarin + ASA 100 mg + PPI (Drug)
Warfarin + ASA 300 mg + PPI
In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis
干预措施: Warfarin + ASA 300 mg + PPI (Drug)
Observational Warfarin
This arm is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4.
干预措施: Observational Warfarin (Drug)
结局指标
主要结局
Increased thrombus size
时间窗: 6 months
Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
Complications
时间窗: 6 months
Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion Nonfatal minor complication: Bleeding without need for transfusion, TIA.
Decreased thrombus size
时间窗: 6 months
Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
Same thrombus size
时间窗: 6 months
Thrombus size remains as similar as the previous transesophageal echocardiographic examination findings in the absence of any fatal and non fatal major complications
次要结局
未报告次要终点
研究者
MEHMET OZKAN
Principal Investigator, MD., Prof., Head of Cardiology
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital