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Pharmacogenomics of Antiplatelet Response (PARes-III)

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aspirin

About this trial

This is an interventional basic science trial for Atherosclerosis focused on measuring aspirin, atherosclerosis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aspirin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02234427

First Posted

September 5, 2014

Last Updated

November 10, 2016

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT02234427

Brief Title

Pharmacogenomics of Antiplatelet Response

Acronym

PARes-III

Official Title

Pharmacogenomics of Antiplatelet Response

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

Keywords

aspirin, atherosclerosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aspirin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Description

2-week aspirin therapy (81mg/day)

Primary Outcome Measure Information:

Title

Differential Gene Expression

Description

Time Frame

2-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rehan Qayyum, MD

Organizational Affiliation

Johns Hopkins School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.genestarstudy.com

Description

GeneSTAR Research Program

Learn more about this trial

Pharmacogenomics of Antiplatelet Response

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