Pharmacogenomics of Antiplatelet Response

Atherosclerosis Clinical Trial

— PARes-III  

Official title:

Pharmacogenomics of Antiplatelet Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234427
• Other study ID #: PARes-III
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2014
• Last updated: September 4, 2015
• Start date: June 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• Aspirin
2-week aspirin therapy (81mg/day)

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differential Gene Expression	differences in platelet transcriptome before and after 2-week aspirin therapy	2-weeks	No

External Links

•   GeneSTAR Research Program