NCT00818753已完成2 期
The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis
研究概览
简要总结
To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dabigatran 110 mg
Experimental
experimental drug therapy in this indication
干预措施: dabigatran 110 mg (Drug)
Dabigatran 150 mg
Experimental
experimental drug therapy in this indication
干预措施: dabigatran 150 mg (Drug)
Unfractionated Heparin
Active Comparator
standard therapy in this indication as comparator
干预措施: unfractionated heparin (Drug)
结局指标
主要结局
Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis
时间窗: From 22 to 165 minutes
Investigator reported outcome
次要结局
- Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy(From 22 to 165 minutes)
- Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow(From 22 to 165 minutes)
- Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis(From 22 to 165 minutes)
- Number of Participants With Bleeding Events(First administration until 7-14 days after PCI (Percutaneous Coronary Intervention))
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)ThromboembolismNCT00680186Boehringer Ingelheim2,589
已完成
1 期
Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule in Healthy Japanese and Caucasian Male SubjectsHealthyNCT02171468Boehringer Ingelheim48
已完成
3 期
Secondary Prevention of Venous Thrombo Embolism (VTE).ThromboembolismNCT00329238Boehringer Ingelheim2,867
已完成
3 期
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous ThromboembolismThromboembolismNCT00291330Boehringer Ingelheim2,564
Unknown
4 期
The Efficacy and Safety Study of Dabigatran and Warfarin to Non-valvular Atrial Fibrillation PatientsAtrial FibrillationNCT02646267The First Affiliated Hospital with Nanjing Medical University210