跳至主要内容
临床试验/NCT01001260
NCT01001260终止不适用

Biosynthesis of PGD2 in Vascular Injury

University of Pennsylvania0 个研究点目标入组 51 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
51
主要终点
The increment of PGD2 synthesis reflected by an novel biomarker of urinary PGD2 metabolite.

研究概览

简要总结

To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty (PTCA) procedure.

详细描述

A) To determine whether biosynthesis of PGD2 is altered in response to vascular injury in humans

B) Patients will be grouped base on their aspirin using status. Three groups of no aspirin but an alternative anti-platelet medicine, low dose (81 mg) aspirin, high dose 325 mg aspirin will be enrolled.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with existing CAD admitted for elective PTCA:
  • Treated with any dose of aspirin daily for at least 5 days, with special interest in those treated with 81 mg aspirin daily or
  • Treated with an alternative antiplatelet therapy, such as clopidogrel, due to aspirin hypersensitivity or PMDs preference or
  • No aspirin therapy at all
  • Patients presenting to the ER with Acute Coronary Syndrome(ACS)who will have a PTCA
  • Patients with stable angina or positive stress tests scheduled for a cardiac catheterization

排除标准

  • History of unstable diabetes (hgb A1c>8 or FBS> 200)
  • Uncontrolled hypertension (SBP > 180, DBP >100)
  • History of an acute confounding disease as judged on clinical screen that according to the investigator may interfere with interpretation of the study results, or compromise the safety of a potential subject.
  • Patients who have taken NSAIDS or COX-2 inhibitors other than aspirin, for at least 10 days prior to PTCA

研究组 & 干预措施

No Aspirin Treatment

干预措施: No ASA (Drug)

81 mg Aspirin Treatment

干预措施: Low dose ASA (Drug)

325 mg Aspirin

干预措施: 325 mg ASA (Drug)

结局指标

主要结局

The increment of PGD2 synthesis reflected by an novel biomarker of urinary PGD2 metabolite.

时间窗: 18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection.

次要结局

  • Whether aspirin could blunt the increment of PGD2 if there is.(18-48 hours - which includes 24 hours before the procedure through 18 hours after the procedure for a continuous urine collection.)

研究者

申办方类型
Other
责任方
Sponsor

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