EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study
试验速览
- 阶段
- 4 期
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Major bleeding and Mace
研究概览
简要总结
RATIONALE:
Transradial coronary stenting is associated with less risk of access site complications and bleeding compared to femoral approach.
Major bleeding post-PCI is a strong independent predictor of mortality and MACE. Depending of the antithrombotic regimen and access-site used, bleeding related to access-site represents 50-80% of the cases. Whereas transradial approach minimizes the risks of access-site bleeding, it has no impact on non-access site bleeding.
Peri-procedural anemia is also an independent predictor of mortality and MACE.
With femoral approach, bivalirudin compared to heparin ± glycoproteins IIb-IIIa has been associated with a significant reduction in access-site and non-access site related bleeding.
In a post-hoc analysis of patients treated by transradial approach in ACUITY, there was a trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ± glycoproteins IIb-IIIa.
HYPOTHESES:
In patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins IIb-IIIa reduces the risk of bleeding compared to heparin ± glycoproteins IIb-IIIa.
In patients at high-risk of bleeding and undergoing transradial PCI, bivalirudin significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.
详细描述
OBJECTIVES:
The primary objective is to compare the incidence of major bleeding and anemia 24h post-PCI in patients at high-risk of bleeding after transradial PCI with heparin or bivalirudin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least two of the following additional criteria
- •At least 70 yrs old
- •Female gender
- •Creatinine clearance <60mL/min
- •History of gastro-intestinal or other organ bleeding
- •Baseline anemia
- •Current treatment with glycoproteins IIb-IIIa inhibitors
排除标准
- •Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months
- •Concurrent participation in other investigational study
- •Femoral sheath (artery)
研究组 & 干预措施
Bivalirudin
Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
干预措施: Bivalirudin (Drug)
Heparin
70 U/kg or standard practice
干预措施: Heparin (Drug)
结局指标
主要结局
Major bleeding and Mace
时间窗: 24h post-PCI and Discharge
The primary end-points will be 1) the incidence of major bleeding (Replace-2 criteria) at hospital discharge and 2) the incidence of 24h post-PCI anemia (WHO criteria)
次要结局
- EFFICACY and SAFETY PARAMETERS(30 days)
研究者
Olivier F. Bertrand
MD, PhD
Laval University