Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity

NCT02848339 | Completed

• 1 other identifier: GISE
• Study Type: observational
• Target: 330
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aspirin Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

aspirin DRUG

aspirin desensitization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a history of aspirin hypersensitivity presenting with either an acute coronary syndrome or known/suspected stable coronary artery disease scheduled for coronary angiography with intent to undergo PCI

You may qualify if:

• history of aspirin hypersensitivity
• acute coronary syndrome or known/suspected stable coronary artery disease
• intent to undergo percutaneous coronary intervention

You may not qualify if:

• withdrawal of consent

Sponsors & Collaborators

• Italian Society of Cardiology: lead

Related Publications (1)

• Rossini R, Iorio A, Pozzi R, Bianco M, Musumeci G, Leonardi S, Lettieri C, Bossi I, Colombo P, Rigattieri S, Dossena C, Anzuini A, Capodanno D, Senni M, Angiolillo DJ. Aspirin Desensitization in Patients With Coronary Artery Disease: Results of the Multicenter ADAPTED Registry (Aspirin Desensitization in Patients With Coronary Artery Disease). Circ Cardiovasc Interv. 2017 Feb;10(2):e004368. doi: 10.1161/CIRCINTERVENTIONS.116.004368.

  PMID: 28193678 DERIVED

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Ph D

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 28, 2016
• Study Start: May 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 28, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share