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临床试验/NCT02316119
NCT02316119已完成不适用

Mechanisms Involved in the Bleeding Risk of Patients With Coronary Artery Diseased Previous Stroke or Transient Ischemic Attack in Use of Antiplatelet Therapy

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)

研究概览

简要总结

Background: About 5% of patients with acute coronary syndrome (ACS) have had previously ischemic stroke (IS) or transitory ischemic attack (TIA). This is a high-risk population, with a high incidence of ischemic events, and also of bleeding events. While the high ischemic risk in this population is attributed to a higher prevalence of cardiovascular risk factors, their predisposition to bleeding events is not well understood. Hypothesis: The increased bleeding risk in ACS patients with history of cerebrovascular event may be justified by a low platelet activity. Methods: Unicentric, prospective, case-control study, which included approximately 100 post-ACS patients with history of IS/TIA previously to the acute coronary event (Case Group) and 100 patients without IS/TIA (Control group). The groups were matched for gender, age, and ACS type and year of occurrence. All patients were taking aspirin, and the main exclusion criteria were use of dual antiplatelet therapy, previous hemorrhagic stroke, severe renal dysfunction, thrombocytopenia or coagulopathy. Main analysis: Platelet aggregation was evaluated by 6 methods: VerifyNow Aspirin®, VerifyNow P2Y12®, PFA 100®, thrombelastography (ReoRox®), light transmission aggregometry with ADP (LTA ADP) and epinephrine (LTA EPI) as agonists. Additional analysis: genetic, HDL transport and inflammatory evaliation

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Post-ACS patients with history of IS/TIA previously to the acute coronary event and taking aspirin
  • Sign the consent form

排除标准

  • Hemorrhagic stroke
  • Another antiplatelet drug than aspirin
  • Use of Anti inflammatory drug
  • Severe chronic kidney dysfunction
  • Liver disease
  • Coagulopathy
  • Platelet disfunction
  • Thrombocytopenia or thrombocytosis
  • Refuse to sign the consent form

结局指标

主要结局

Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)

时间窗: in the selection visit

次要结局

  • Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units)(in the selection visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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