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The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization

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ClinicalTrials.gov Identifier: NCT00644657
Recruitment Status : Completed
First Posted : March 27, 2008
Results First Posted : October 7, 2011
Last Update Posted : October 7, 2011
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions: Coronary Artery Disease
Chest Pain
Intervention: Drug: Clopidogrel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients scheduled for cardiac catheterization and possible percutaneous intervention who received a loading dose of 300 mg of clopidogrel were recruited.

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 Loading Dose All subjects received a 300 mg loading dose of clopidogrel

Participant Flow:   Overall Study
    Clopidogrel Loading Dose
STARTED   27 
COMPLETED   27 
NOT COMPLETED   0 



  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.
No text entered.

Reporting Groups
  Description
Clopidogrel All 27 subjects received a 300 mg loading dose of clopidogrel

Baseline Measures
   Clopidogrel 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (9) 
Gender 
[Units: Participants]
 
Female   2 
Male   25 
The percentage of platelets that are "coated-Platelets" as measured by dual-agonist stimulation [1] 
[Units: Percent coated platelets]
Mean (Standard Deviation)
 40.0  (14.3) 
[1] In each patient the percentage of platelets that are collagen coated will be measured in each patient before clopidogrel administration.


  Outcome Measures

1.  Primary:   The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty   [ Time Frame: 24 hours after the administration of clopidotrel ]

2.  Secondary:   The Percentage of Coated Platelets After Coronary Angiography and/or PCI   [ Time Frame: 6 hrs after procedure ]


  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
Limited to primarily Male VA population.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Eliot Schechter, MD
Organization: University of Oklahoma Health Sciences Center
phone: 405-456-5378
e-mail: eliot-schechter@ouhsc.edu



Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00644657     History of Changes
Other Study ID Numbers: 13291
First Submitted: March 24, 2008
First Posted: March 27, 2008
Results First Submitted: January 6, 2011
Results First Posted: October 7, 2011
Last Update Posted: October 7, 2011