Is a Reduced Biochemical Response to Aspirin Associated With Increased Cardiovascular Morbidity and Mortality in High Risk Patients With Coronary Artery Disease?
试验速览
- 阶段
- 不适用
- 入组人数
- 906
- 试验地点
- 1
- 主要终点
- Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke
时间窗: Evaluation after 3 years
次要结局
- Single endpoints:cardiovascular death; acute myocardial infarction; ischemic stroke; stent thrombosis; all-cause death(Evaluation after 3 and 5 years)
- Combined secondary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke(Evaluation after 5 years)
