Aspirin Response in High Risk Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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Previous studies indicate that patients with cardiovascular disease have a variable response to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial infarction. This has given rise to the phenomenon aspirin low-responsiveness. Laboratory aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet production of thromboxane A2 or inhibit thromboxane-dependent platelet aggregation. Whether a low platelet response to aspirin results in an increased risk of future thrombotic events is of great clinical significance, but is still unknown. The investigators hypothesize that patients with a reduced response to aspirin, determined by platelet aggregation using the apparatus Verify Now Aspirin and Multiplate, have a higher risk of thrombosis. The purpose of this study is to investigate whether a higher incidence of cardiovascular events is found in patients with coronary artery disease (CAD) having a reduced biochemical response to aspirin compared with CAD patients having a normal biochemical response to aspirin. In addition to CAD, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.

Official Title
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Is a Reduced Biochemical Response to Aspirin Associated With Increased Cardiovascular Morbidity and Mortality in High Risk Patients With Coronary Artery Disease?

Conditions
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Coronary Artery Disease, Myocardial Infarction, Diabetes Mellitus, Renal Insufficiency, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary artery disease verified by coronary angiogram Treatment with aspirin 75 mg/d for at least the previous 7 days Previous myocardial infarction more than one year ago (groups with previous myocardial infarction) Type 2 diabetes mellitus treated with oral antidiabetics and/or insulin (groups with type 2 diabetes mellitus) Renal insufficiency; glomerular filtration rate <60 ml/min at the time of blood sampling (groups with renal insufficiency) Exclusion Criteria: Treatment with NSAIDs, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drugs known to affect platelet function Ischemic vascular event within the previous 12 months Revascularization (angioplasty or coronary by-pass graft surgery) within the previous 12 months Platelet count <120 x 10^9/L or >450 x 10^9/L For patients without diabetes: fast glucose >7 mmol/L Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke |  | Evaluation after 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined secondary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke |  | Evaluation after 5 years | 
| Single endpoints:cardiovascular death; acute myocardial infarction; ischemic stroke; stent thrombosis; all-cause death |  | Evaluation after 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet aggregation, Aspirin, Drug resistance, Thromboxane B2, Pharmacologic Actions, Platelet Aggregation Inhibitors