Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity (ADAPTED)

Italian Society of Cardiology

Status: Completed

Conditions: Aspirin Hypersensitivity

Treatments: Drug: aspirin

Study type: Observational

Funder types: Other

Identifiers

NCT02848339

GISE

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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