Prevalence of Resistance to Aspirin and/or Clopidogrel Among Patients With PAD. Prognostic Significance of Resistance to Aspirin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Myocardial infarction, Unstable angina, Cerebral infarction, Transitory cerebral ischaemia, Percutaneous or surgical vascular intervention, Sudden deterioration of symptoms, Amputation, Death.
研究概览
简要总结
263 patients with peripheral atherosclerosis were examined to evaluate the activity of the platelets during the standard treatment, including aspirin. A subgroup of 43 received 600 mg of clopidogrel 2 h before platelet reactivity analysis.
The main hypothesis is that high platelet activity at the beginning of the study is associated with a higher risk of atherothrombosis. Follow up time is 5 years.
详细描述
Patients with peripheral atherosclerosis are at high risk of atherothrombosis, mainly heart attack and stroke. The medical treatment of these patients include platelet inhibiting drugs, usually aspirin, to reduce the risk of ischemic events. Clopidogrel is another platelet inhibiting drug, which is prescribed less often, primarily because of the high costs compared to aspirin.
Phenomena of 'resistance' to these drugs have been described by numerous investigators. Essentially resistance means that the effect of the drug described is less than expected or missing, as measured by various laboratory methods. We do not know which way resistance is best described, but it has been described that patients who are 'resistant' to either drug are less protected against future heart attacks or strokes.
Main objectives:
- To measure the activity of platelets in these patients during aspirin treatment.
- To measure the activity of platelets in a minor population of these patients during clopidogrel treatment.
- To evaluate the prognostic significance of resistance to aspirin in these patients.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Atherosclerosis of the lower limbs, defined by one of the following criteria: Ankle-Brachial Pressure Index (ABPI)< 0.9, intermittent claudication, ischaemic pain at rest, ischaemic ulcers or gangrene.
- •Age > 18 years
- •For fertile women: Use of safe contraception (intrauterine contraceptive device, the pill, hormonal skin patches, progestogen injections, progestogen implant, vaginal ring)
排除标准
- •Allergy to either Aspirin or Clopidogrel
- •Known bleeding disorder
- •Platelet count < 140 mia/L or > 400 mia/L
- •Intake of NSAID's, SSRI's or Dipyridamol within the preceding 14 days
- •Not radically treated gastrointestinal ulceration within the last 6 month
- •Greater surgical procedures performed within the last 3 month
- •Severe renal disease
- •Severe hepatic disease
- •Breast feeding
- •Pregnancy
研究组 & 干预措施
Aspirin
All participants get Aspirin, and platelet reactivity measurements are performed.
干预措施: Aspirin (Drug)
结局指标
主要结局
Myocardial infarction, Unstable angina, Cerebral infarction, Transitory cerebral ischaemia, Percutaneous or surgical vascular intervention, Sudden deterioration of symptoms, Amputation, Death.
时间窗: 5 years
次要结局
未报告次要终点
研究者
Esben Hjorth Madsen
M.D.
Aalborg University Hospital