Evaluation of Safety, Benefits and Complications of Long-term Dual Antiplatelet Therapy in Patients With Angioplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,010
- 主要终点
- Number of Patients With Major Bleeding Need Transfusion
研究概览
简要总结
1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were compared to evaluate safety and feasibility of long term Plavix therapy post stenting.
详细描述
1010 patients from registry of angioplasty and stenting in Shiraz and Baghiatolah hospital were enrolled and long term Plavix therapy more than and less than 12 months were compared between two groups of patients prospectively and rate of major adverse cardiovascular events ( MACE) (death, myocardial infarction, cerebrovascular accidents and revascularization) and rate of bleeding were compared between 2 groups.Syntax score and American heart association ( AHA) score of coronary involvement were measured and MACE was compared to these scores.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •post stent ( lesion more than 70% and vessel more than 2.25 mm )
排除标准
- •allergy to acetylsalicylic acid or clopidogrel,
- •planned surgery within 24 months of percutaneous coronary intervention unless the dual antiplatelet therapy could be maintained throughout the perisurgical period
- •history of bleeding diathesis
- •major surgery within 15 days
- •active bleeding
- •previous stroke in the past 6 months
- •concomitant or foreseeable need for oral anticoagulation therapy
- •pregnancy, life expectancy <24 months, participation in another trial
- •inability to provide informed consent
研究组 & 干预措施
plavix long term
taking plavix more than 12 months
干预措施: plavix (Drug)
plavix short term
taking plavix less than 12 months
干预措施: plavix (Drug)
结局指标
主要结局
Number of Patients With Major Bleeding Need Transfusion
时间窗: 12 months
number of patients with major bleeding need transfusion
Number of Patients With Central Vascular Accidents Proved by CT Scan
时间窗: 12 months
the number of patients with major vascular brain accidents ( CVA) proved by CT scan
Number of Patients With Myocardial Infarction Need Hospital Admission
时间窗: 12 month
The number of patients with myocardial infarction need hospital admission
Number of Patients With Death Due to Cardiac Causes
时间窗: 12 months
the number patients with death due to cardiac causes
Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty
时间窗: 12 months
need for redo bypass surgery and redo angioplasty
Number of Patients With Minor Bleeding
时间窗: 12 months
the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes
次要结局
- Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues(12 months)
研究者
Javad Kojuri
professor
Shiraz University of Medical Sciences