NCT04471870已完成不适用
Multicentre Observational, Prospective Cohort Study Including Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention Who Receive Cangrelor i.v. Transitioning to Clopidogrel, Prasugrel or Ticagrelor Per os
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,005
- 试验地点
- 33
- 主要终点
- Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria
研究概览
简要总结
The Sponsor implemented a post-authorisation safety study (PASS), category 3, focused in Acute Coronary Syndrome, in order to collect information about the safety of cangrelor in the real clinical practice, evaluating the safety of the transition to all the oral P2Y12 inhibitors (cangrelor, ticagrelor and prasugrel).
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' written informed and privacy consent obtained before or at the end of the PCI procedure according to patients' condition but in any case, prior to collection of any study-related data;
- •Male or female patients aged ≥ 18 years;
- •Patients with acute coronary syndromes undergoing PCI;
- •Patients who are planned to be treated with cangrelor, or who have received treatment with cangrelor.
排除标准
- •Patients with active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension;
- •Patients with history of stroke or transient ischaemic attack (TIA);
- •Patients with hypersensitivity to the active substance (cangrelor) or to any of its excipients;
- •Known pregnancy or breast-feeding female patients;
- •Patients with stable angina (SA).
结局指标
主要结局
Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria
时间窗: 30 days post-PCI
The incidence will be calculated as the ratio between the number of patients experiencing at least one event during the 30-day observation period over the total number of evaluable patients.
次要结局
- Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria(30 days after PCI)
- Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria(30 days after PCI)
- Incidence of major adverse cardiac events (MACE)(30 days after PCI)
- To describe the type of oral platelet P2Y12 receptor (prasugrel/ticagrelor/clopidogrel)(30 days after PCI)
- To describe the use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors(30 days after PCI)
- Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria(48 hours after PCI)
- Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria(48 hours after PCI)
- Incidence of major adverse cardiac events (MACE)(48 hours after PCI)
研究者
研究点 (33)
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