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

Primary Purpose

Coronary Artery Disease, Chest Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clopidogrel
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coronary Artery Disease focused on measuring Platelets, platelet aggregation inhibitors

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention

Exclusion Criteria:

  • Acute coronary syndrome
  • Unable to tolerate clopidogrel

Sites / Locations

  • VA Medical Center, 1F187

Outcomes

Primary Outcome Measures

The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty
The percentage of platelets that are collagen coated after the administration of clopidogrel.

Secondary Outcome Measures

The Percentage of Coated Platelets After Coronary Angiography and/or PCI
The percentage of coated platelets 24 hours after coronary angiography and/or PCI

Full Information

First Posted
March 24, 2008
Last Updated
September 7, 2011
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT00644657
Brief Title
The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization
Official Title
The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.
Detailed Description
Platelet activity will be determined by light transmission aggregometry at baseline, after a 300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. The change in the percentage of platelets that are coated platelets will be determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Chest Pain
Keywords
Platelets, platelet aggregation inhibitors

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
All subjects will receive a 300 mg loading dose
Primary Outcome Measure Information:
Title
The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty
Description
The percentage of platelets that are collagen coated after the administration of clopidogrel.
Time Frame
24 hours after the administration of clopidotrel
Secondary Outcome Measure Information:
Title
The Percentage of Coated Platelets After Coronary Angiography and/or PCI
Description
The percentage of coated platelets 24 hours after coronary angiography and/or PCI
Time Frame
6 hrs after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention Exclusion Criteria: Acute coronary syndrome Unable to tolerate clopidogrel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliot Schechter, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, 1F187
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104-5076
Country
United States

12. IPD Sharing Statement

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

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