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临床试验/NCT01383304
NCT01383304Unknown不适用

Is a Reduced Biochemical Response to Aspirin Associated With Increased Cardiovascular Morbidity and Mortality in High Risk Patients With Coronary Artery Disease?

University of Aarhus1 个研究点 分布在 1 个国家目标入组 906 人开始时间: 2007年11月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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