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Aspirin Desensitization Registry in Patients With Aspirin Hypersensitivity (ADAPTED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02848339
First Posted: July 28, 2016
Last Update Posted: July 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roberta Rossini, Italian Society of Cardiology
  Purpose

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.


Condition Intervention
Aspirin Hypersensitivity Drug: aspirin

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Aspirin DesensitizAtion in PatienTs With Coronary artEry Disease: Results of a Multi Center Registry: the ADAPTED Registry

Resource links provided by NLM:


Further study details as provided by Roberta Rossini, Italian Society of Cardiology:

Primary Outcome Measures:
  • 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.

  • 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


Enrollment: 330
Study Start Date: May 2010
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aspirin
    aspirin desensitization
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Roberta Rossini, MD Ph D, Italian Society of Cardiology
ClinicalTrials.gov Identifier: NCT02848339     History of Changes
Other Study ID Numbers: GISE
First Submitted: July 22, 2016
First Posted: July 28, 2016
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics