Practice Patterns of Antithrombotic Therapy in REAL-world Patients Undergoing PCI in Spain: Parenteral Antiplatelet Agents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 717
- 试验地点
- 12
- 主要终点
- Rate of Net Adverse Clinical Events (NACE)
研究概览
简要总结
This registry will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the PCI (Percutaneous Coronary Intervention) setting and will investigate as well the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of "real-world" patients undergoing PCI in Spain.
详细描述
The present study is an observational, multicenter, nationwide, prospective investigation in patients undergoing PCI due to any coronary syndrome (acute or chronic) and receiving parenteral antiplatelet agents, GPIs or cangrelor, as per clinical practice during the procedure.
This investigation will provide exploratory and descriptive information regarding contemporary practice patterns of parenteral antiplatelet therapy in the PCI setting and will evaluate the short-term effectiveness and safety of the currently available parenteral antiplatelet agents in a cohort of patients undergoing PCI in Spain.
Approximately 15 high-volume PCI-capable Spanish centers will participate in the present investigation with the intention to enroll circa 1.000 patients.
The study is purely observational and no intervention will be performed in the included subjects because due to their participation in this investigation.
Patients fulfilling inclusion and exclusion criteria will be included after providing written informed consent to participate in the current investigation. Patient characteristics, procedural details and pharmacological therapies will be collected after inclusion and clinical events will be registered at two time points: 48 hours and 30 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age ≥18 years
- •Undergoing a PCI
- •Use of a parenteral antiplatelet agent (GPIs or cangrelor)during the invasive procedure (PCI)
排除标准
- •Blood dyscrasia, bleeding diathesis or active bleeding at the time of the index procedure.
- •Chronic oral anticoagulation.
- •Recent history of stroke, TIA (Transient Ischemic Attack)or intracranial bleeding (<3 months prior to inclusion).
- •Severe anemia (Hb<9g/dl) or platelet count <100x106/ml at the time of the index procedure.
- •Any active neoplasm.
研究组 & 干预措施
Patients undergoing PCI
干预措施: Parenteral antiplatelet agents (Other)
结局指标
主要结局
Rate of Net Adverse Clinical Events (NACE)
时间窗: 48 hours
NACE defined as a the composite of all-cause death, recurrent myocardial infarction, stroke, target vessel revascularization, definite or probable stent thrombosis and BARC bleeding (type 2,3 and 5) will be evaluated at 48 hours from index procedure
次要结局
- Stroke(30 days)
- Cardiac death(30 days)
- Definite or probable stent thrombosis(30 days)
- BARC bleeding(30 days)
- Death(30 days)
- Myocardial infarction(30 days)
- Target Vessel Revascularization(30 days)
- Rate of Net Adverse Clinical Events (NACE)(30 days)
- Transition to oral P2Y12 inhibitors(24 hours)
- Death(48 hours)
- Myocardial infarction(48 hours)
- Stroke(48 hours)
- Target Vessel Revascularization(48 hours)
- Definite or probable stent thrombosis(48 hours)
- BARC bleeding(48 hours)
- Cardiac death(48 hours)