跳至主要内容
临床试验/NCT01820429
NCT01820429已完成不适用

Residual Platelet Activity Despite Aspirin Utilization in Patients With Non ST Elevation Acute Coronary Syndromes: Comparison Between the Acute and Chronic Phases

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2009年12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
70
试验地点
1
主要终点
Compare platelet aggregation between the first 48 hours and 3 months after discharge.

研究概览

简要总结

The purpose of this study is to compare the response to aspirin in the acute phase with the late phase of an acute coronary syndrome.

详细描述

The purpose of this study is to compare, in the same population, the response to aspirin in the initial phase (first 48 hours) with the late phase (after 3 months of discharge)of a non ST elevation acute coronary syndrome (angina or acute myocardial infarction).

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

  • Age ≥ 18 years
  • Confirmed diagnosis of acute coronary syndrome without ST segment elevation, in the first 48 hours after the onset of the clinical symptoms
  • Regular use of aspirin for at least seven days.

排除标准

  • Previous use, in the last 7 days, of another antiplatelet agent than aspirin
  • Use of antivitamin K in the last 3 weeks
  • Hemoglobin < 10g/dL and / or hematocrit < 30% or > 50%, platelets count < 100.000/mm3 or > 500.000/mm3, creatinine clearance < 30 mL / minute
  • Killip class III or IV
  • Need for vasopressor or inotropic parenteral medication at inclusion in the study
  • Percutaneous coronary intervention within 30 days or CABG in the last 90 days prior to study entry
  • Current malignancy
  • Hematologic diseases
  • Refusal to sign the inform consent form
  • Unable to attend the second visit (follow-up) for any reason except for death

结局指标

主要结局

Compare platelet aggregation between the first 48 hours and 3 months after discharge.

时间窗: 3 months

次要结局

  • Relation between the atherosclerotic burden by coronary angiography with the platelet aggregation in the first 48 hours.(48 hours)
  • Relation between C reactive protein and interleukin -6 with levels of platelet aggregation.(first 48 hours and 3 months)
  • Relation between platelet aggregation and the presence or absence of selected polymorphisms.(first 48 hours and 3 months)
  • Relation between platelet aggregability and the composite endpoint of death, myocardial infarction, unstable angina and need for revascularization or hospitalization at 3 months after discharge.(3 months)
  • Platelet aggregation in respect to age, gender, glucose at hospital arrival, glycated hemoglobin, statin, PPI, current smokers, ACE inhibitors, type of ACS presentation.(first 48 hours and 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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