Clopidogrel Resistance and Platelet Reactivity in Women Undergoing Percutaneous Coronary Intervention

Completed

• Conditions: Coronary Artery Disease; Acute Coronary Syndrome

• Registration Number: NCT01796873
• Lead Sponsor: University of Arizona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-22
• Status Verified: 2013-07
• Primary Completion: 2014-01
• Study Completion: 2014-04
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet Reactivity measured by the VerifyNow P2Y12 Assay	At least 14 days following the ACS event	Compare the Hispanic female platelet reactivity response to the Caucasian female platelet reactivity response in females currently taking clopidogrel.

Trial Locations

Locations (2)

University of Arizona Medical Center South Campus; 🇺🇸 Tucson, Arizona, United States

University of Arizona Medical Center University Campus; 🇺🇸 Tucson, Arizona, United States