NCT02848339

Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 330 (actual)
• Sponsor: Italian Society of Cardiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aspirin Hypersensitivity

Interventions

Type	Name	Description
DRUG	aspirin	aspirin desensitization

Timeline

• Start date: 2010-05-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2016-07-28
• Last updated: 2016-07-28