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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00644657
Other study ID # 13291
Secondary ID
Status Completed
Phase N/A
First received March 24, 2008
Last updated September 7, 2011
Start date March 2007
Est. completion date September 2008

Study information

Verified date September 2011
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Acute coronary syndrome

- Unable to tolerate clopidogrel

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Drug:
Clopidogrel
All subjects will receive a 300 mg loading dose

Locations

Country Name City State
United States VA Medical Center, 1F187 Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 hours after the administration of clopidotrel No
Secondary The Percentage of Coated Platelets After Coronary Angiography and/or PCI The percentage of coated platelets 24 hours after coronary angiography and/or PCI 6 hrs after procedure No
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