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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02848339
Acronym
ADAPTED
Enrollment
330
Registered
2016-07-28
Start date
2010-05-31
Completion date
2015-02-28
Last updated
2016-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspirin Hypersensitivity

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.

Interventions

DRUGaspirin

aspirin desensitization

Sponsors

Italian Society of Cardiology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients with successful desensitization procedure12 monthsAll patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure.
Major adverse cardiac events12 monthsPercentage of patients with an adverse cardiac event (cardiac death, myocardial infarction, stent thrombosis, stroke, destabilizing symptoms leading to hospitalization

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026