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ASPIRIN (ASA) AND CAROTID ENDARTERECTOMY

ASPIRIN (ASA) AND CAROTID ENDARTERECTOMY
阿司匹林 (ASA) 和颈动脉内膜切除术
批准号:
2271291
负责人:
DOUGLAS W TAYLOR
金额:
$106.2万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1994
资助国家:
美国
项目状态:
已结题
起止时间:
1994-04-14 至 1997-03-31

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中文摘要
翻译
最近来自2项大型临床试验的证据已经牢固地确立了 颈动脉内膜切除术(CE)对症状性高血压患者的益处 分级颈动脉狭窄。目前正在进行的试验将进一步确定 这种外科手术对无症状患者和那些 颈动脉中度狭窄科学的增长 CE调查,发现致死性和非致死性 中风后的程序,导致了CE的使用增加。 这种情况可能会继续下去。虽然行政长官能带来长远利益,但 也是中风和死亡的重大直接围手术期风险。 因此,至关重要的是,我们要研究减少这种情况的方法。 风险 NASCET试验的一项非对照观察结果表明, 可能通过简单的方案降低CE的围手术期风险 包括每日剂量650至1300 mg阿萨, 手术虽然阿萨在预防中风方面的价值已经很清楚, 在过去十年中建立的,在适当的 一级预防的剂量,没有关于剂量的有用信息 对接受颈动脉手术的患者的影响。在 拟定试验,计划在中心进行颈动脉内膜切除术的患者 目前参加NASCET合作研究组,将是 手术前,随机分配至4种药物方案之一,包括 阿萨每日剂量80 mg、325 mg、650 mg或1300 mg,继续 90天这些患者将从手术开始随访3个月, 记录所有中风、死亡和功能状态的变化。这些 结果将构成比较4种阿萨剂量的基础 组 美国和加拿大各有大约10万人接受CE 年目前,这些患者中约有6%或6000人患有中风或中风。 手术后30天内死亡。如果将该事件发生率降低50%, 因此,每年有3000人免于中风和死亡, 给那些提供和接受这一点的人增加信心 外科手术拟议的审判将确定是否这样做 利益存在,并提供所需的信息,以估计 使用简单阿萨可实现的风险降低幅度 治疗方案。
英文摘要
Recent evidence from 2 large clinical trails has firmly established the benefit of carotid endarterectomy (CE) for patients with symptomatic high grade carotid stenosis. Trials currently underway will further define the role of this surgical procedure for asymptomatic patients and for those with more moderate carotid stenosis. The increased scientific investigation of CE, and discovery of a reduction in fatal and non-fatal stroke following the procedure, has led to an increase in the use of CE. This is likely to continue. Although CE produces long term benefits, there is also a substantial immediate perioperative risk of stroke and death. Consequently, it is crucial that we investigate means of reducing this risk. An uncontrolled observation from the NASCET trial suggests that it may be possible to reduce the perioperative risk of CE through a simple regimen consisting of a daily dose of 650 to 1300 mg of ASA started prior to surgery. Although the value of ASA in stroke prevention has been clearly established over the last decade, disagreement exists over the appropriate dose for primary prevention and no useful information exists on dosage effects in patients undergoing surgery to the carotid artery. In the proposed trial, patients scheduled for carotid endarterectomy at centers currently participating in the NASCET collaborative study group, will be randomly assigned, before surgery, to one of 4 drug regimens consisting of ASA at a daily dose of 80 mg, 325 mg, 650 mg, or 1300 mg, to be continued for 90 days. These patients will be followed for 3 months from surgery to record all strokes, deaths and changes in functional status. These outcomes will form the basis for the comparison of the 4 ASA dosage groups. Approximately 100,000 individuals undergo CE in the U.S.A. and Canada each year. Currently about 6%, or 6000, of these patients suffer stroke or death within 30 days of surgery. A 50% reduction in this event rate would thus spare 3000 individuals from stroke and death each year, and would give increased confidence to both those offering and those receiving this surgical procedure. The proposed trial will determine whether such benefits exist and provide the information needed to estimate the magnitude of risk reduction that might be achievable with a simple ASA treatment regimen.
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ASPIRIN (ASA) AND CAROTID ENDARTERECTOMY
  • 批准号:
    2271292
  • 项目类别:
  • 资助金额:
    $69.98万
  • 财政年份:
    1994
  • 负责人:
    DOUGLAS W TAYLOR
  • 依托单位:
ASPIRIN (ASA) AND CAROTID ENDARTERECTOMY
  • 批准号:
    2271290
  • 项目类别:
  • 资助金额:
    $93.6万
  • 财政年份:
    1994
  • 负责人:
    DOUGLAS W TAYLOR
  • 依托单位:
海外基金