Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity (ADAPTED)

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

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.

Study Overview

• Status: Completed
• Conditions: Aspirin Hypersensitivity
• Intervention / Treatment: Drug: aspirin

• Study Type: Observational
• Enrollment (Actual): 330

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Italian Society of Cardiology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: GISE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No