Aspirin DesensitizAtion in PatienTs With Coronary artEry Disease: Results of a Multi Center Registry: the ADAPTED Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 主要终点
- Percentage of patients with successful desensitization procedure
研究概览
简要总结
Data about aspirin desensitization for patients with coronary artery disease undergoing percutaneous coronary intervention are sparse.
This is a prospective, multicenter, observational study including 7 italian centers, to assess safety and feasibility of a standard desensitization protocol in patients with aspirin sensitivity undergoing coronary angiography. Patients with history of aspirin sensitivity undergoing coronary angiography are prospectively enrolled.All patients underwent the desensitization procedure with six sequential doses of aspirin (1, 5, 10, 20, 40, and 100 mg) administered orally at predefined intervals, with the procedure lasting 5.5 hours.All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure, and in hospital major adverse cardiac events (MACE). All patients are also followed-up for 12 months in order to assess their long-term risk of MACE, compliance with ASA therapy, and late occurrence of side reactions due to ASA sensitivity.
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
- •history of aspirin hypersensitivity
- •acute coronary syndrome or known/suspected stable coronary artery disease
- •intent to undergo percutaneous coronary intervention
排除标准
- •withdrawal of consent
结局指标
主要结局
Percentage of patients with successful desensitization procedure
时间窗: 12 months
All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure.
Major adverse cardiac events
时间窗: 12 months
Percentage of patients with an adverse cardiac event (cardiac death, myocardial infarction, stent thrombosis, stroke, destabilizing symptoms leading to hospitalization
次要结局
未报告次要终点
研究者
Roberta Rossini
MD Ph D
Italian Society of Cardiology
