Laboratory Aspirin Resistance in Diabetics and Non-Diabetics

Study Overview
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Brief Summary
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Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It has been speculated that these patients might be resistant to aspirin, and studies have indicated that this phenomenon is related to a less favourable prognosis. Furthermore, patients with diabetes mellitus have an increased risk of myocardial infarction and other vascular events and, recently, it has been suggested that diabetics do not respond adequately to aspirin. The purpose of this study is to compare the prevalence of aspirin resistance in diabetics and non-diabetics. Furthermore, patients who suffered a myocardial infarction while being treated with aspirin are included. We hypothesize that the prevalence of aspirin resistance will be higher among diabetics compared to other patients and to healthy individuals.

Detailed Description
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A considerable number of patients suffer acute coronary events despite being treated with antiplatelet therapy such as aspirin. Taken together with laboratory findings of a low response to aspirin, the term aspirin resistance has been coined. Diabetics have an increased risk of suffering ischemic vascular events and, recently, an increased prevalence of aspirin resistance was reported in these patients. The purpose of the present study is to compare the aspirin response in diabetics and non-diabetics in a population with angiogram-verified coronary artery disease. Furthermore, healthy volunteers and patients who suffered a myocardial infarction while being treated with aspirin are included. Eligible patients are identified in the Western Denmark Heart Registry.

Official Title
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Laboratory Aspirin Resistance in Coronary Artery Disease Patients With or Without Diabetes Mellitus

Conditions
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Drug Resistance

Intervention / Treatment
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* Drug: acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic heart disease verified by coronary angiogram (group:CAD) treatment with aspirin 75 mg/d for at least the previous 7 days(groups: CAD and Previous myocardial infarction) type II diabetes mellitus ( 50% of groups: CAD and Previous myocardial infarction) ≥ 1 myocardial infarction more than one year ago while taking daily aspirin ≥ 75 mg/d (group: Previous myocardial infarction). 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 intake of NSAIDs within 1 week of myocardial infarction (group: Previous myocardial infarction). platelet count < 120 x 10^9/l previous myocardial infarction (group: CAD). not able 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: acetylsalicylic acid|75 mg/d for 7 days (healthy volunteers) and continued treatment with 75 mg/d in patients taking daily aspirin.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet aggregation |  | (at least) one hour after aspirin ingestion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelets, Platelet aggregation, Drug resistance, Aspirin, Diabetes mellitus