Pharmacogenomics of Antiplatelet Response

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-05-31

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

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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.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Aspirin

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

2-week aspirin therapy (81mg/day)

Interventions

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Aspirin

2-week aspirin therapy (81mg/day)

Intervention Type DRUG

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No