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OpenTrials
Completed

NCT Number: NCT02848339

Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity

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.

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Key information

Conditions

Aspirin Hypersensitivity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

aspirin desensitization

Primary outcomes

  1. Percentage of patients with successful desensitization procedure

    Time frame: 12 months

    All patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure.

  2. Major adverse cardiac events

    Time frame: 12 months

    Percentage of patients with an adverse cardiac event (cardiac death, myocardial infarction, stent thrombosis, stroke, destabilizing symptoms leading to hospitalization

Sponsors and collaborators

Lead sponsor

Italian Society of Cardiology

Other

Registry information

Official study title

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

Acronym: ADAPTED

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 28, 2016
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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