Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery. A Prospective Observational Study (OBTAIN Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 830
- 试验地点
- 3
- 主要终点
- 1. MACE
研究概览
简要总结
Research questions:
- What is the absolute risk reduction for in-hospital major adverse cardiac events (MACE) associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population?
- What is the absolute risk increase for clinically significant bleeding during the same period associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population?
In brief the design of the study is as follows:
- We will study patients undergoing non-cardiac surgery within four years of coronary stenting.
- We will record the anti-platelet agents taken by patients before, during and after surgery.
- We will record cardiac and bleeding events that occur whilst the patient is in hospital.
- We will use the statistical technique of propensity scoring to match patients who have similar risk factors and who received different anti-platelet regimens.
- We will compare the incidence of cardiac events and bleeding in the matched groups.
详细描述
This study will compare the use of aspirin alone with dual antiplatelet therapy (i.e. aspirin and clopidogrel) in patients presenting for elective non-cardiac surgery who have undergone PCI with either bare metal stent or drug eluting stent placement in the four years prior to surgery. The absolute risk reduction in major adverse cardiac events (MACE) with dual antiplatelet therapy and the absolute risk increase for clinically significant bleeding events with dual therapy will be determined. This will allow the number needed to treat (NNT) for the prevention of MACE and the number needed to harm (NNH) for bleeding to be determined and the optimal antiplatelet therapy in this setting to be identified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients undergoing non-cardiac surgery within four years of percutaneous coronary intervention (PCI) with the placement of a bare metal or drug eluting stent will be included in the study.
排除标准
- •Patients maintained on anticoagulant therapy e.g. heparin infusion before and after surgery will be excluded. (Patients receiving prophylactic doses of heparin for prevention of thromboembolic events will be eligible for inclusion.)
- •Patients receiving bridging therapy with full anticoagulant does of heparin or other drugs to compensate for the withdrawal of antiplatelet drugs will be excluded.
- •Patients who are anticoagulated with warfarin (INR>1.5 at the time of surgery) will be excluded.
- •Patients receiving full anticoagulation with heparin for a known recent a known thromboembolic event (APPT ratio > 1.5) be excluded. -
结局指标
主要结局
1. MACE
时间窗: In-hospital stay up to 30 days
This study will record and analyse in-hospital adverse cardiac events. Major Adverse Cardiac Events (MACE) will be defined as a composite of: 1. Myocardial infarction as defined by the Universal Definition of Myocardial Infarction(including cardiac arrest and cardiac death as described in this definition). 2. PCI for a cardiac event occurring following surgery.
2. Clinically significant bleeding
时间窗: In-hospital stay up to 30 days
This study will record and analyse in-hospital clinically significant bleeding. Clinically Significant Bleeding Events will be defined as: 1. Reoperation for bleeding. 2. Gastrointestinal haemorrhage 3. Intracranial haemorrhage 4. Spinal/epidural haematoma. The transfusion of blood and blood products will also be recorded and compared between patients on dual antiplatelet therapy and aspirin alone.
次要结局
未报告次要终点