Safety and Efficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery for Coronary Artery Disease Patients Treated With Oral Antiplatelet Agents
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 950
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
Patients with coronary artery disease, especially after PCI, require long-term oral antiplatelet therapy. However, this patient population may inevitably require non-cardiac surgery for a variety of conditions. In order to avoid the occurrence of bleeding events, oral antiplatelet agents are usually discontinued before non-cardiac surgery in patients with coronary artery disease, which may increase the incidence of ischemic events. Therefore, it is important to provide patients with the optimal perioperative antithrombotic treatment to balance the risk of bleeding and ischemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or over
- •Established coronary artery disease being treated with oral antiplatelet therapy
- •Non-cardiac surgery is planned and bridging antithrombotic therapy is considered necessary
- •Agree to participate in the study and provide written informed consent
排除标准
- •According to the consensus of Chinese experts on antiplatelet therapy in 2013, the surgical bleeding risk is low or extremely low
- •Requiring emergency non-cardiac surgery within 24 hours after admission
- •Currently being bleeding
- •Moderate or severe ischemic stroke or spontaneous intracranial hemorrhage in the past 6 months or traumatic intracranial hemorrhage in the past 1 year
- •Intracranial diseases or hemorrhagic diathesis
- •Contraindications for LMWH or GP IIb/IIIa receptor antagonists
结局指标
主要结局
Major adverse cardiovascular events
时间窗: Perioperative period
A composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke
次要结局
- TIMI major or minor bleeding(Perioperative period)
- Net adverse clinical events(30 days after surgery)
研究者
Yujie Zhou
PhD, MD
Beijing Anzhen Hospital