Aspirin Response in High Risk Patients With Coronary Artery Disease
This trial is active, not recruiting.
|Conditions||coronary artery disease, myocardial infarction, diabetes mellitus, renal insufficiency, chronic|
|Sponsor||University of Aarhus|
|Collaborator||Aarhus University Hospital Skejby|
|Start date||November 2007|
|End date||January 2011|
|Trial size||906 participants|
|Trial identifier||NCT01383304, 22527|
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.
Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke
time frame: Evaluation after 3 years
Combined secondary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke
time frame: Evaluation after 5 years
Single endpoints:cardiovascular death; acute myocardial infarction; ischemic stroke; stent thrombosis; all-cause death
time frame: Evaluation after 3 and 5 years
Male or female participants at least 18 years old.
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
|Official title||Is a Reduced Biochemical Response to Aspirin Associated With Increased Cardiovascular Morbidity and Mortality in High Risk Patients With Coronary Artery Disease?|
|Principal investigator||Anne-Mette Hvas, MD, Ph.D|
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