Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity (ADAPTED)
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|ClinicalTrials.gov Identifier: NCT02848339|
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
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.
|Condition or disease||Intervention/treatment|
|Aspirin Hypersensitivity||Drug: aspirin|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||330 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Aspirin DesensitizAtion in PatienTs With Coronary artEry Disease: Results of a Multi Center Registry: the ADAPTED Registry|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
- Drug: aspirin
- Percentage of patients with successful desensitization procedure [ Time Frame: 12 months ]All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure.
- Major adverse cardiac events [ Time Frame: 12 months ]Percentage of patients with an adverse cardiac event (cardiac death, myocardial infarction, stent thrombosis, stroke, destabilizing symptoms leading to hospitalization