Clopidogrel Resistance and Platelet Reactivity in Women Undergoing Percutaneous Coronary Intervention

August 20, 2024 updated by: University of Arizona

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85713
        • University of Arizona Medical Center South Campus
      • Tucson, Arizona, United States, 85724
        • University of Arizona Medical Center University Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Reactivity measured by the VerifyNow P2Y12 Assay
Time Frame: 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.
At least 14 days following the ACS event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Sasanka Jayasuriya, MD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimated)

February 22, 2013

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-0021-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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