Pharmacogenomics of Antiplatelet Response

Phase 4

Completed

• Conditions: Atherosclerosis
• Interventions: Drug: Aspirin

• Registration Number: NCT02234427
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-09
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Results First Submitted: 2016-08-01
• Status Verified: 2016-11
• Results First Submitted QC: 2016-11-10
• Last Update Submitted: 2016-11-10
• Results First Posted: 2017-01-09
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin	-

Primary Outcome Measures

Name	Time	Method
Differential Gene Expression	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

Trial Locations

Locations (1)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States