Clopidogrel Resistance and Platelet Reactivity in Women Undergoing Percutaneous Coronary Intervention

NCT01796873 | Completed

• 1 other identifier: 12-0021-01
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Keywords

Female; Hispanic; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Platelet Reactivity measured by the VerifyNow P2Y12 Assay

  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

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Taking any of the following antiplatelet drugs:
• Prasugrel (Effient)
• Ticagrelor (Brilinta)
• Ticlopidine (Ticlid)

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (2)

University of Arizona Medical Center South Campus

Tucson, Arizona, 85713, United States

Location

University of Arizona Medical Center University Campus

Tucson, Arizona, 85724, United States

Location

Related Publications (3)

• 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.

  PMID: 23333143 BACKGROUND

• 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.

  PMID: 18804739 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Sasanka Jayasuriya, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 22, 2013
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 22, 2024

Record last verified: 2013-07

Locations

US (2)