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Pharmacogenomics of Antiplatelet Response - I (PARes-I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rehan Qayyum, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01815008
First received: March 18, 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: Prevention
Conditions: Platelet Aggregation
Platelet Transcriptome
Coronary Artery Disease
Interventions: Drug: Clopidogrel
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Clopidogrel

Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily

Clopidogrel: Clopidogrel 75 mg daily

Aspirin: Aspirin 81 mg daily


Participant Flow:   Overall Study
    Clopidogrel
STARTED   19 [1] 
COMPLETED   15 [2] 
NOT COMPLETED   4 
[1] Had difficulty in completing enrollment
[2] transcriptomic data was available on 9 participants only



  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.
No text entered.

Reporting Groups
  Description
Clopidogrel

Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily

Clopidogrel: Clopidogrel 75 mg daily

Aspirin: Aspirin 81 mg daily


Baseline Measures
   Clopidogrel 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.9  (5.2) 
Gender 
[Units: Participants]
Count of Participants
 
Female      6  42.9% 
Male      8  57.1% 
Race/Ethnicity, Customized 
[Units: Participants]
 
African Americans   14 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Difference in ADP-induced Platelet Aggregation   [ Time Frame: at baseline and at 1 week ]

2.  Secondary:   Difference in Arachidonic Acid-induced Platelet Aggregation   [ Time Frame: At baseline and after 1-week ]

3.  Secondary:   Difference in Collagen-induced Platelet Aggregation   [ Time Frame: At Baseline and at 1 week ]

4.  Secondary:   Changes in Platelet Transcriptome With Clopidogrel   [ Time Frame: At baseline and at 1 week ]


  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: NCT01815008     History of Changes
Other Study ID Numbers: K23HL105897-PARes-I
K23HL105897 ( US NIH Grant/Contract Award Number )
Study First Received: March 18, 2013
Results First Received: August 1, 2016
Last Updated: November 10, 2016