PERcutaneouS Coronary intErventions in Patients Treated With Oral Anticoagulant Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,080
- 试验地点
- 10
- 主要终点
- Net Adverse Clinical Event
研究概览
简要总结
Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. There are many possible different combinations of the antithrombotic therapy after stent implantation in these patients.
Aim of this observational study is to evaluate the real world antithrombotic treatment in patients requiring anticoagulant therapy undergoing stent implantation and to compare the clinical outcome of patients treated with new oral anticoagulant drugs compared to warfarin.
The study is prospective, performed in different Italian hospitals and aimed to enroll 1080 patients with a 1 year follow up
详细描述
Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. These patients pose particular problems when undergo percutaneous coronary intervention with stent implantation (PCI-S), because of the different antithrombotic and oral anticoagulant (OAC) strategies required after the procedure when dual antiplatelet therapy is recommended. Consequently, this scenario requires careful consideration balancing bleeding, stroke and acute coronary syndrome risks.
New oral anticoagulants (NOAC) have been compared to warfarin for stroke prevention in the setting of atrial fibrillation and all these drugs showed a similar or improved efficacy over warfarin in term of ischemic events as well as bleeding complications reduction. In particular, an important safety issue is the reduction of intracranial bleeding compared to warfarin. Currently, four different NOAC have been approved for the treatment of patients with atrial fibrillation: apixaban, edoxaban, rivaroxaban and dabigatran. The first three drugs are anti Xa inhibitors whereas the last one is a direct thrombin inhibitor.
Data regarding the combination of NOAC and antiplatelet therapy after PCI-S in patients requiring chronic anticoagulant therapy are currently scarce.
The aim of our study is to perform a prospective, multicenter, observational, controlled study on patients requiring chronic anticoagulant treatment with either vitamin K antagonists or NOAC undergoing PCI-S for concomitant coronary disease.
The primary objectives of the study are:
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
- •All patients undergoing percutaneous coronary interventions with stent and an indication for chronic anticoagulant therapy.
排除标准
- •Patients of age < 18 years old
- •Lack of written informed consent to participate in the study
结局指标
主要结局
Net Adverse Clinical Event
时间窗: 1 year
major bleeding, myocardial infarction, death, stroke, myocardial revascularization
次要结局
未报告次要终点