RIsk of Apoplexia Cerebri in CLOpidogrel Non-responders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Number of patient with new stroke
研究概览
简要总结
Stroke patients are given prophylactic treatment with clopidogrel to prevent new strokes. Some of these patients (the investigators don't know precisely how many, but previous studies indicate 4-34%) are so called non-responders, when you measure on a blood sample from the patient. These patients may have an increased risk for less effect of the treatment and therefore a higher risk for a new stroke.
The investigators want to investigate if clopidogrel non-responders have a clinically increased risk of a new stroke by following the patients for two years. With this study the investigators aim to ensure that all patients get the best prophylactic treatment and reduce the risk of early death and dependency of others.
详细描述
Background and purpose
Patients, who have had a stroke, have an increased risk of a new stroke. Clinical trials have proven that inhibition of blood platelets reduce the risk of a new stroke. Unfortunately there are patients not responding (non-responders) to anti-platelet treatment. Patients not responding might have a greater risk of a new stroke compared to patients responding (responders) to anti-platelet treatment.
These clinical trials does not take into account that an unknown number of the patients are unresponsive (non-responders) to inhibition of blood platelet treatment and thereby in a poorer prophylactic treatment than necessary and have a higher risk of early death, disability and depending upon others.
Trials of other anti-platelet regimes (acetylsalicylic acid) have shown that 33 % of stroke patients are non-responders and that they had an 10 times increased risk of vascular death, myocardial infarction or stroke in the first two years after the stroke and start of treatment. Therefore it is likely that it is of great clinical importance to identify non-responders to optimize therapy.
Today Clopidogrel is the drug-of-choice in prophylactic stroke treatment. To our knowledge no one has studied the non-responder problem of Clopidogrel as prophylactic treatment in stroke patients. Due to genetic differences, data from other studies can't be transferred to Danish patients.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to neurological department with stroke signs om CT or MRI or history consistent with stroke and gives clopidogrel 75 mg as prophylactic treatment.
排除标准
- •cancer diagnosis Other anti platelet treatment
研究组 & 干预措施
Stroke
clopidogrel 75 mg
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Number of patient with new stroke
时间窗: 2 years
次要结局
- Number of patients with transitory ischemic attack(2 years)