Physiopathology of Rapid Aspirin Desensitization

NCT01118546 | Completed

• 1 other identifier: P051026
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Hypersensitivity; Coronary Artery Disease

Keywords

aspirin; coronary artery disease; hypersensitivity; Platelet aggregation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Ongoing ST elevation acute coronary syndrome
• Ongoing signs or symptoms of hypersensitivity or allergy (asthma, urticaria, Quincke' edema, or other allergic symptoms)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre hospitalier Bichat Claude Bernard

Paris, 75018, France

Location

Related Links

• Publication

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and urine

MeSH Terms

Conditions

Hypersensitivity; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Immune System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gabriel STEG, Pr

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: May 6, 2010
• Study Start: February 1, 2007
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 29, 2016

Record last verified: 2015-02

Locations

FR (1)