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Pharmacogenomics of Antiplatelet Response (PARes-III)

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Johns Hopkins University

Status and phase

Completed
Phase 4

Conditions

Atherosclerosis

Treatments

Drug: Aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT02234427
PARes-III

Details and patient eligibility

About

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

Full 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.

Enrollment

34 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

Aspirin
Experimental group
Treatment:
Drug: Aspirin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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