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Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity

NCT02848339 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2016-07-28

No results posted yet for this study

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

DRUG

aspirin

aspirin desensitization

Sponsors & Collaborators

  • Italian Society of Cardiology

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2015-02-28
Completion
2015-02-28

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02848339 on ClinicalTrials.gov