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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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Atherosclerosis
Intervention: Drug: Aspirin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Aspirin Aspirin: 2-week aspirin therapy (81mg/day)

Participant Flow:   Overall Study
    Aspirin
STARTED   34 
COMPLETED   33 [1] 
NOT COMPLETED   1 
[1] One individual withdrew after first visit



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Aspirin Aspirin: 2-week aspirin therapy (81mg/day)

Baseline Measures
   Aspirin 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.4  (10.3) 
Gender 
[Units: Participants]
Count of Participants
 
Female      17  50.0% 
Male      17  50.0% 
Race/Ethnicity, Customized 
[Units: Participants]
 
African Americans   17 
Caucasians   17 


  Outcome Measures

1.  Primary:   Differential Gene Expression   [ Time Frame: 2-weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rehan Qayyum
Organization: Johns Hopkins School of Medicine
phone: 410-955-7781
e-mail: rqayyum@jhmi.edu



Responsible Party: Rehan Qayyum, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02234427     History of Changes
Other Study ID Numbers: PARes-III
First Submitted: September 5, 2014
First Posted: September 9, 2014
Results First Submitted: August 1, 2016
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017