Aspirin Response in High Risk Patients With Coronary Artery Disease

University of Aarhus

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT01383304

22527

Details and patient eligibility

About

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.

Enrollment: 906 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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