Aspirin Response in High Risk Patients With Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

906 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2017-01-31

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.

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Detailed Description

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Conditions

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Coronary Artery Disease Myocardial Infarction Diabetes Mellitus Renal Insufficiency, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No