NCT00616460已完成3 期
ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- End points: Primary :Major & minor bleeding Port of entry related complications
研究概览
简要总结
To determine the safety/efficacy of Bivallirudin Vs unfractionated heparin (UFH) on top of dual antiplatelet therapy in patients with high tendency for bleeding during urgent and elective 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
- Double (Participant, Investigator)
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
- •Inclusion criteria (any of the following):
- •≥75 years
- •Creatinin clearance rate < 60 ml per minute
- •Anemia (Hb 9-11 mg%)
- •Hypertension: BP > 180/95 mmHg but less than 210/110 m Hg
- •Diabetic Pts
- •Steroid treated Pts
- •Recent (within 6 weeks) non major surgery
- •Pts with hematological disorders associated with tendency for bleeding like Thrombocytopenia (platelets 50000-150000) included TTP;
排除标准
- •Exclusion criteria:
- •Age < 18 year
- •Acute STEMI (Primary PCI)*
- •Rescue angioplasty <12h after lytic therapy*
- •Active bleeding
- •S.C LMWH < 8 hours or UFH < 4 hours before PCI
- •Using IIb /IIIa as an upstream therapy before PCI
- •PCI which will be involved with obligatory IIb /IIIa therapy:
- •(thrombotic complication, occlusive dissection)
- •INR>1.5 on day of cathetrization
- •Bolus of 600mg of Clopidogrel before PCI
- •Current pregnancy or women in reproductive age without contraceptives
- •Hypersensitivity to heparin or bivalirudin or its components *(possible using IIB/IIIA)
研究组 & 干预措施
Bivalirudin
Experimental
干预措施: Bivalirudin (Drug)
结局指标
主要结局
End points: Primary :Major & minor bleeding Port of entry related complications
时间窗: 30 days
次要结局
- End points: Secondary: 30 days MACE(30 days)
研究者
Turgeman Yoav
Chief of Cardiology Department
HaEmek Medical Center, Israel
研究点 (1)
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