Clinical trial NCT01796873: Clopidogrel Resistance and Platelet Reactivity in Women Undergoing Percutaneous Coronary Intervention
Official title: Clopidogrel Resistance and Platelet Reactivity in Hispanic Females Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Coronary Artery Disease
Keywords: Female
Hispanic
Percutaneous Coronary Intervention
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 36
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Platelet Reactivity measured by the VerifyNow P2Y12 Assay
timeFrame: At least 14 days following the ACS event
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center South Campus
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Medical Center University Campus
state: Arizona
Study officials:
affiliation: University of Arizona
name: Sasanka Jayasuriya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Baber U. et al., Impact of Self-Reported Ethnicity on Response to Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2010;122:A20850