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Pharmacogenomics of Antiplatelet Response (PARes-III)

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ClinicalTrials.gov Identifier: NCT02234427
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Rehan Qayyum, 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

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: Aspirin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacogenomics of Antiplatelet Response
Study Start Date : June 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin Drug: Aspirin
2-week aspirin therapy (81mg/day)




Primary Outcome Measures :
  1. Differential Gene Expression [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234427


Locations
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United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Rehan Qayyum, MD Johns Hopkins School of Medicine

Additional Information:
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Responsible Party: Rehan Qayyum, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02234427    
Other Study ID Numbers: PARes-III
First Posted: September 9, 2014    Key Record Dates
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017
Last Verified: November 2016
Keywords provided by Rehan Qayyum, Johns Hopkins University:
aspirin, atherosclerosis
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics