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

This study has been completed.

Study NCT00644657 Information provided by University of Oklahoma

First Received on March 24, 2008. Last Updated on September 7, 2011 History of Changes

Results First Received: January 6, 2011

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Basic Science
Conditions:	Coronary Artery Disease Chest Pain
Intervention:	Drug: Clopidogrel

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
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
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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

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Reporting Groups

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

Baseline Measures

	Clopidogrel
Number of Participants [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

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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 ]

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2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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.

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

No publications provided

Responsible Party:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00644657 History of Changes
Other Study ID Numbers:	13291
Study First Received:	March 24, 2008
Results First Received:	January 6, 2011
Last Updated:	September 7, 2011
Health Authority:	United States: Institutional Review Board