Clopidogrel Resistance and Platelet Reactivity in Women Undergoing Percutaneous Coronary Intervention

NCT ID: NCT01796873

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-04-30

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sasanka Jayasuriya, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona Medical Center South Campus

Tucson, Arizona, United States

Site Status

University of Arizona Medical Center University Campus

Tucson, Arizona, United States

Site Status

Countries

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United States

References

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Frelinger AL 3rd, Bhatt DL, Lee RD, Mulford DJ, Wu J, Nudurupati S, Nigam A, Lampa M, Brooks JK, Barnard MR, Michelson AD. Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet function. J Am Coll Cardiol. 2013 Feb 26;61(8):872-9. doi: 10.1016/j.jacc.2012.11.040. Epub 2013 Jan 16.

Reference Type BACKGROUND
PMID: 23333143 (View on PubMed)

Wenaweser P, Daemen J, Zwahlen M, van Domburg R, Juni P, Vaina S, Hellige G, Tsuchida K, Morger C, Boersma E, Kukreja N, Meier B, Serruys PW, Windecker S. Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study. J Am Coll Cardiol. 2008 Sep 30;52(14):1134-40. doi: 10.1016/j.jacc.2008.07.006.

Reference Type BACKGROUND
PMID: 18804739 (View on PubMed)

Baber U. et al., Impact of Self-Reported Ethnicity on Response to Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2010;122:A20850

Reference Type BACKGROUND

Other Identifiers

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12-0021-01

Identifier Type: -

Identifier Source: org_study_id

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