Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity

Completed

• Conditions: Aspirin Hypersensitivity

• Registration Number: NCT02848339
• Lead Sponsor: Italian Society of Cardiology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-07
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-27
• Last Update Submitted: 2016-07-27
• Study First Posted: 2016-07-28
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• history of aspirin hypersensitivity
• acute coronary syndrome or known/suspected stable coronary artery disease
• intent to undergo percutaneous coronary intervention

Exclusion Criteria

• withdrawal of consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with successful desensitization procedure	12 months	All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure.
Major adverse cardiac events	12 months	Percentage of patients with an adverse cardiac event (cardiac death, myocardial infarction, stent thrombosis, stroke, destabilizing symptoms leading to hospitalization