Clopidogrel Resistance and Platelet Reactivity in Women Undergoing Percutaneous Coronary Intervention

This study is currently recruiting participants.
Verified February 2013 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
Sasanka Jayasuriya, University of Arizona
ClinicalTrials.gov Identifier:
NCT01796873
First received: February 19, 2013
Last updated: February 21, 2013
Last verified: February 2013

February 19, 2013
February 21, 2013
January 2012
June 2013   (final data collection date for primary outcome measure)
Platelet Reactivity measured by the VerifyNow P2Y12 Assay [ Time Frame: At least 14 days following the ACS event ] [ Designated as safety issue: No ]
Compare the Hispanic female platelet reactivity response to the Caucasian female platelet reactivity response in females currently taking clopidogrel.
Same as current
Complete list of historical versions of study NCT01796873 on ClinicalTrials.gov Archive Site
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Clopidogrel Resistance and Platelet Reactivity in Women Undergoing Percutaneous Coronary Intervention
Clopidogrel Resistance and Platelet Reactivity in Hispanic Females Undergoing Percutaneous Coronary Intervention

Plavix (clopidogrel) is a drug that is approved by the FDA (Food and Drug Administration) to reduce the risk of having another heart attack by preventing platelets (blood cells that are important in forming blood clots) from sticking together and forming another clot. Platelet activity can be measured by a machine called VerifyNow.

The purpose of this study is to see whether Hispanic women and White non-Hispanic women have the same platelet response to a commonly used drug, Plavix (clopidogrel). Recent studies have shown that platelets may be more active in Hispanics, making it more difficult to prevent clots from forming, even when using Plavix. In addition, studies have shown that women may also have more active platelets than men. There have been no studies of Hispanic women and the effect of Plavix on platelet activity.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Females, age ≥ 45 years, with Acute Coronary Syndrome (ACS), undergone a percutaneous coronary intervention and currently treated with clopidogrel will be enrolled. The subjects' race and ethnicity will be self -reported and Hispanic ethnicity by self-report of having both parents of Hispanic/Latino descent.

  • Acute Coronary Syndrome
  • Coronary Artery Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
October 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All females age 45 or greater, presenting to University of Arizona Medical Center South Campus or University Campus Cardiology service with a history of ACS
  • Hispanics will be defined via self-reporting as having both parents of Latino descent
  • Currently taking clopidogrel

Exclusion Criteria:

  • Taking any of the following antiplatelet drugs:

    • Prasugrel (Effient)
    • Ticagrelor (Brilinta)
    • Ticlopidine (Ticlid)
Female
45 Years and older
No
Contact: Deborah Strootman, BSN 520-626-1201 dstrootman@shc.arizona.edu
United States
 
NCT01796873
12-0021-01
No
Sasanka Jayasuriya, University of Arizona
University of Arizona
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Principal Investigator: Sasanka Jayasuriya, MD University of Arizona
University of Arizona
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP