Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)
研究概览
简要总结
The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
详细描述
There are growing numbers of endocardial permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) device. Asymptomatic obstruction of the access vein reported to have a high incidence (30-50%) in some studies. This complication can cause some difficulties in follow up procedures such as device upgrading. The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 who referred for first implantation of pacemaker, implantable cardiac defibrillator, or cardiac re synchronization therapy device
排除标准
- •history of malignancy
- •history of coagulopathy or platelet disorder
- •history of venous thromboembolism
- •history of gastrointestinal hemorrhage or active gastroduodenal ulcer in past 6 months
- •history of chronic kidney disorder or serum creatinine more than 1.5 mg/dl
- •patients who are on anticoagulant or other antithrombotic drugs or who must be on dual antiplatelet therapy.
研究组 & 干预措施
placebo
No antiplatelet drug
干预措施: placebo (Drug)
Aspirin
Aspirin 80 mg daily
干预措施: Aspirin 80 mg daily (Drug)
Clopidogrel
Clopidogrel 75mg daily
干预措施: Clopidogrel 75 mg daily (Drug)
结局指标
主要结局
Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)
时间窗: 3 months
次要结局
- major bleeding(3 months)
- A composite of death of any cause, myocardial infarction, or cerebrovascular accident.(3 months)
研究者
Mohammad Ali Akbarzadeh
Assistant proffesor of shahid beheshti university of medical sciences
Shahid Beheshti University of Medical Sciences