Physiopathology of Rapid Aspirin Desensitization

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 Outcome Measures	Not Provided
Original Other 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, Senior)
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