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临床试验/NCT02234427
NCT02234427已完成4 期

Pharmacogenomics of Antiplatelet Response

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
34
试验地点
1
主要终点
Differential Gene Expression

研究概览

简要总结

This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene expression in persons at high-risk of developing heart attacks due to family history of early-onset coronary artery disease

详细描述

In this clinical trials we will select individuals from GeneSTAR cohort based o their platelet function. Equal number of individuals will be selected from each race and gender and from low or high platelet aggregation. We will have baseline platelet functions performed and baseline platelet gene expression examined. Participants will be given 2-week supply of aspirin(81 mg/daily) and will be examined at the end of 2-weeks with platelet aggregation studies and a repeat platelet gene-expression (using RNA-seq). The ultimate goal is to examine platelet gene expression differences due to aspirin and across different gender, race, platelet-aggregation groups.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 45-75 years
  • GeneSTAR participant
  • No personal History of Coronary Artery Disease
  • Women who are post-menopausal
  • Women who are using a reliable method of contraception, such as history of tubal ligation, IUD or taking OCP

排除标准

  • Taking aspirin prescribed by physician
  • weight < 60 kg
  • History of recent or current bleeding
  • allergy to aspirin or history of adverse events to aspirin
  • serious comorbid conditions (such as AIDS, active cancer)
  • high blood pressure (>160/95)
  • History of gastrointestinal ulcer/bleeding
  • Mental incompetence to make decision to participate.

研究组 & 干预措施

Aspirin

Experimental

干预措施: Aspirin (Drug)

结局指标

主要结局

Differential Gene Expression

时间窗: 2-weeks

Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rehan Qayyum

Assistant Professor

Johns Hopkins University

研究点 (1)

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