ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 27

Recruitment Details Patients scheduled for cardiac catheterization and possible percutaneous intervention who received a loading dose of 300 mg of clopidogrel were recruited.
Pre-assignment Details  
Arm/Group Title Clopidogrel Loading Dose
Hide Arm/Group Description All subjects received a 300 mg loading dose of clopidogrel
Period Title: Overall Study
Started 27
Completed 27
Not Completed 0
Arm/Group Title Clopidogrel
Hide Arm/Group Description All 27 subjects received a 300 mg loading dose of clopidogrel
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
64  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
2
   7.4%
Male
25
  92.6%
The percentage of platelets that are "coated-Platelets" as measured by dual-agonist stimulation   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent coated platelets
Number Analyzed 27 participants
40.0  (14.3)
[1]
Measure Description: In each patient the percentage of platelets that are collagen coated will be measured in each patient before clopidogrel administration.
1.Primary Outcome
Title The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty
Hide Description The percentage of platelets that are collagen coated after the administration of clopidogrel.
Time Frame 24 hours after the administration of clopidotrel
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Loading Dose
Hide Arm/Group Description:
All subjects received a 300 mg loading dose of clopidogrel
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: Percent of platelets that are coated.
32.8  (13.6)
2.Secondary Outcome
Title The Percentage of Coated Platelets After Coronary Angiography and/or PCI
Hide Description The percentage of coated platelets 24 hours after coronary angiography and/or PCI
Time Frame 6 hrs after procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Loading Dose
Hide Arm/Group Description:
All subjects received a 300 mg loading dose of clopidogrel
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: Percentage of platelets that are coated
33.9  (12.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clopidogrel Loading Dose
Hide Arm/Group Description All subjects received a 300 mg loading dose of clopidogrel
All-Cause Mortality
Clopidogrel Loading Dose
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clopidogrel Loading Dose
Affected / at Risk (%)
Total   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Clopidogrel Loading Dose
Affected / at Risk (%)
Total   0/27 (0.00%) 
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
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