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Completed

NCT Number: NCT02234427

Pharmacogenomics of Antiplatelet Response

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

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Aspirin

Drug

2-week aspirin therapy (81mg/day)

Primary outcomes

  1. Differential Gene Expression

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: PARes-III

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 9, 2014
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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