Pharmacogenomics of Antiplatelet Response

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Pharmacogenomics of Antiplatelet Response

Conditions
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Atherosclerosis

Intervention / Treatment
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* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin<br> | Drug: Aspirin<br>* 2-week aspirin therapy (81mg/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential Gene Expression | 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 | 2-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin, atherosclerosis