Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity

Aspirin Hypersensitivity Clinical Trial

— ADAPTED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848339
• Other study ID #: GISE
• Status: Completed
• Phase: N/A
• First received: July 22, 2016
• Last updated: July 27, 2016
• Start date: May 2010
• Est. completion date: February 2015

Study information

• Verified date: July 2016
• Source: Italian Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aspirin Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• aspirin
aspirin desensitization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Italian Society of Cardiology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with successful desensitization procedure	All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure.	12 months	Yes
Primary	Major adverse cardiac events	Percentage of patients with an adverse cardiac event (cardiac death, myocardial infarction, stent thrombosis, stroke, destabilizing symptoms leading to hospitalization	12 months	No