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Pharmacogenomics of Antiplatelet Response - II (PARes-II) (PARes-II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rehan Qayyum, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01894555
First received: July 3, 2013
Last updated: November 10, 2016
Last verified: November 2016
Results First Received: August 1, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Atherothrombosis
Intervention: Drug: Aspirin

  Participant Flow
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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

Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.

Aspirin: 81 mg daily for 4 weeks


Participant Flow:   Overall Study
    Aspirin
STARTED   33 
COMPLETED   33 
NOT COMPLETED   0 



  Baseline Characteristics
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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

Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.

Aspirin: 81 mg daily for 4 weeks


Baseline Measures
   Aspirin 
Overall Participants Analyzed 
[Units: Participants]
 33 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.6  (8.0) 
Gender 
[Units: Participants]
Count of Participants
 
Female      15  45.5% 
Male      18  54.5% 
Race/Ethnicity, Customized 
[Units: Participants]
 
African Americans   22 
Caucasians   11 


  Outcome Measures

1.  Primary:   Changes in Platelet Transcriptome   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: NCT01894555     History of Changes
Other Study ID Numbers: K23HL105897-PARes-II
K23HL105897 ( US NIH Grant/Contract Award Number )
Study First Received: July 3, 2013
Results First Received: August 1, 2016
Last Updated: November 10, 2016