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Clopidogrel Resistance and Platelet Reactivity in Women Undergoing Percutaneous Coronary Intervention

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by University of Arizona.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Sasanka Jayasuriya, University of Arizona Identifier:
First received: February 19, 2013
Last updated: February 21, 2013
Last verified: February 2013

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.

Condition Phase
Acute Coronary Syndrome
Coronary Artery Disease
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clopidogrel Resistance and Platelet Reactivity in Hispanic Females Undergoing Percutaneous Coronary Intervention

Resource links provided by NLM:

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
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.

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01796873

Contact: Deborah Strootman, BSN 520-626-1201

United States, Arizona
University of Arizona Medical Center South Campus Recruiting
Tucson, Arizona, United States, 85713
Contact: Deborah Strootman, BSN    520-626-1201   
Principal Investigator: Sasanka Jayasuriya, MD         
Sub-Investigator: Kwan S. Lee, MD         
Sub-Investigator: Deborah H Strootman, BSN         
University of Arizona Medical Center University Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Deborah Strootman, BSN    520-626-1201   
Principal Investigator: Sasanka Jayasuriya, MD         
Sponsors and Collaborators
University of Arizona
Principal Investigator: Sasanka Jayasuriya, MD University of Arizona
  More Information

Responsible Party: Sasanka Jayasuriya, Principal Investigator, University of Arizona Identifier: NCT01796873     History of Changes
Other Study ID Numbers: 12-0021-01
Study First Received: February 19, 2013
Last Updated: February 21, 2013

Keywords provided by University of Arizona:
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 24, 2017