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Physiopathology of Rapid Aspirin Desensitization

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ClinicalTrials.gov Identifier: NCT01118546
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date March 31, 2010
First Posted Date May 6, 2010
Last Update Posted Date September 29, 2016
Study Start Date February 2007
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2010)
Platelet aggregation in response to arachidonic acid Basophil activation tests Platelet aggregation in response to arachidonic acid Basophil activation tests [ Time Frame: day 1, after aspirin desensitization ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01118546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Physiopathology of Rapid Aspirin Desensitization
Official Title Physiopathology of Rapid Aspirin Desensitization in Patients With Coronary Artery Disease and a History of Hypersensitivity to Aspirin or NSAIDs
Brief Summary Aspirin is very effective in protecting patients with coronary artery disease against adverse cardiac events, because it is a potent "antiplatelet agent". Some patients may develop a history of hypersensitivity to aspirin and treatment cannot usually be resumed in these patients. We have developed a rapid procedure to induce tolerance in these patients (SILBERMAN et al, Am J CARDIOL 2005;95:509-10) and wish to test whether aspirin is as effective as antiplatelet agent in patients with a history of allergy to aspirin and who undergo desensitization as it is in patients without history of hypersensitivity
Detailed Description

Previous studies in allergology have proved the safety of desensitization procedures in allergic patients with an imperative indication for a medication. This tolerance state is usually obtained after a cumbersome procedure requiring several hours to days. We have adapted successfully such a procedure to the patients with acute coronary artery disease requiring urgent aspirin (excluding the ST elevation myocardial infarction) (SILBERMAN et al, Am J CARDIOL 2005;95:509-10).

Patients with a history of Aspirin or NonSteroidal Anti-Inflammatory Drugs hypersensitivity appear to have alterations of eicosanoid metabolism : these drugs trigger an imbalance toward the leucotriene pathway. This case-control study aims to

  • evaluate after desensitization therapy the anti-aggregant effect of aspirin in these very particular patients : clinical outcome, PFA test, levels of the urinary metabolite of thromboxane A2 (11 dehydro thromboxane B2) and also usual aggregation tests.
  • assess the in VITRO basophil activation induced by aspirin before and after desensitization procedure by flow cytometric cellular allergen test using basophils surface marker and mediators' dosage. Before the challenge procedure these tests aim to confirm the clinically established diagnosis of hypersensitivity. After desensitization, these tests intend to better assess the efficiency of the induced tolerance, to attempt to identify predictors of successful desensitization as well as identify potential cross reactivity with other NSAIDs..

This procedure is indicated in all patients with aspirin or NSAID intolerance with imperative cardiological indications for aspirin, such as acute coronary syndrome, or placement of a stent. The desensitization procedure must be performed in a coronary care unit; the patients are duly informed about benefits and risks of the challenge and provide written informed consent. Desensitization consists in rapidly escalating aspirin dose administration with ad hoc aspirin capsules prepared by the hospital pharmacist. Blood and urinary samples are obtained during the hospital stay for coronary and desensitization care. An additional blood and urine sample will be obtained 6 to 8 weeks later during an outpatient visit in the laboratory. Initial biological data will be compared to those of two control groups matched for age, gender and type of acute coronary syndrome :

  • Controls 1: patients with CAD on aspirin, without history of hypersensitivity
  • Controls 2: patients without CAD, not on aspirin and without history of hypersensitivity.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
plasma and urine
Sampling Method Non-Probability Sample
Study Population Patients with coronary artery disease and a history of aspirin hypersensitivity, requiring treatment with aspirin , referred to an academic tertiary center for desensitization
Condition
  • Hypersensitivity
  • Coronary Artery Disease
Intervention Not Provided
Study Groups/Cohorts
  • controls 2
    patient without CAD, not on aspirin and without history of hypersensitivity
  • case of hypersensitivity
    patient with CAD on aspirin, with a history of hypersensitivity
  • controls 1
    patient with CAD on aspirin, without history of hypersensitivity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 11, 2011)
86
Original Estimated Enrollment
 (submitted: May 5, 2010)
90
Actual Study Completion Date June 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

INCLUSION CRITERIA:

  • Age > 18 years
  • Admitted to Hospital BICHAT, in Cardiology
  • Patients with aspirin or NSAID intolerance due to hypersensitivity
  • Imperative cardiological indications for aspirin, such as acute coronary syndrome, or placement of a stent
  • Written informed consent
  • Patient with health insurance coverage

EXCLUSION CRITERIA:

  • Ongoing ST elevation acute coronary syndrome
  • Ongoing signs or symptoms of hypersensitivity or allergy (asthma, urticaria, Quincke' edema, or other allergic symptoms)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01118546
Other Study ID Numbers P051026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Gabriel STEG, Pr APHP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2015