跳至主要内容
临床试验/NCT02848339
NCT02848339已完成不适用

Aspirin DesensitizAtion in PatienTs With Coronary artEry Disease: Results of a Multi Center Registry: the ADAPTED Registry

Italian Society of Cardiology0 个研究点目标入组 330 人开始时间: 2010年5月最近更新:
适应症
相关药物

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

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

发起方
Italian Society of Cardiology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberta Rossini

MD Ph D

Italian Society of Cardiology

相似试验