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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
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
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Platelet aggregation in response to arachidonic acid Basophil activation tests Platelet aggregation in response to arachidonic acid Basophil activation tests | day 1, after aspirin desensitization |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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Patients with coronary artery disease and a history of aspirin hypersensitivity, requiring treatment with aspirin , referred to an academic tertiary center for desensitization
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel STEG, Pr | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier Bichat Claude Bernard | Paris | 75018 | France |
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| Label | URL |
|---|---|
| Publication | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 23, 2017 | |
| Reset | May 3, 2017 | |
| Release | Jul 24, 2017 | |
| Reset | Feb 2, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 23, 2017 | May 3, 2017 | |||
| Jul 24, 2017 |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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plasma and urine
| Feb 2, 2018 |
| D002318 |
| Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |