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Clinical Trials

Topic   Cardiology
Title   Tailored Anti-platelet Initiation to Lesson Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI)
Summary   TAILOR-PCI is a multi-site, prospective study that uses a research genetic buccal (mouth swab) test to detect the presence of a liver enzyme that may reduce the effectiveness of standard clopidogrel anti-platelet (blood thinner) treatment after PCI coronary stent placement. CYP2C19 is a genetic liver enzyme abnormality that has been found to reduce the blood thinning effect of clopidogrel. Ticagrelor is a newer anti-platelet (blood thinning) drug that is not dependent on CYP2C19 activation to work. The study hypothesis (or proposed explanation) is that testing patients who are undergoing PCI for the presence of CYP2C19 liver enzyme and treating those who have the abnormal enzyme with ticagrelor instead of clopidogrel, will reduce major adverse cardiac health events (such as heart attack) in patients who have the CYP2C19 genetic abnormality.
Description  

TAILOR-PCI is a multi-site study that is looking at medication treatment for patients after percutaneous coronary intervention (PCI). PCI is a medical intervention for blocked coronary arteries or for patients who are suffering a heart attack. A small mesh tube, called a stent is placed to help increase the size of the narrowed or blocked arteries and to improve blood and oxygen flow to the heart. After coronary stent placement there is a risk of blood clots, so patients are routinely given anti-platelet (blood thinning) medications to prevent blood clot formation. Clopidogrel is an anti-platelet medication approved by the US Federal Drug Administration (FDA) for use in patients who undergo coronary stent placement.

There have been some research studies that show that the effectiveness of clopidogrel may be decreased in patients who have a certain genetic liver enzyme (protein) abnormality. This variation is known as the cytochrome P450 2C19 [CYP2C19] *2 or *3 allele, CYP2C19. A research buccal genetic test (mouth swab) can determine whether or not someone has the CYP2C19 enzyme abnormality. Ticagrelor, is a newer anti-platelet drug that is also FDA approved and is also used for patients after PCI stent placement. Unlike Clopidogrel, Ticagrelor does not depend on the CYP2C19 liver enzyme activation to be effective.

Patients who are undergoing PCI will be randomized, meaning chosen by a coin flip type procedure to one of two groups in the study. The first study group will receive the usual clopidogrel medication treatment after PCI and will not have any research genetic mouth swab test. The second group will have the research genetic mouth swab test for CPY2C19 abnormality and will either be assigned to ticagrelor if the CYP2C19 abnormality is present, or to clopidogrel if the CYP2C19 abnormality is not present.

All patients will have research blood samples drawn for DNA (genetic) analysis, but the blood samples will not be processed until the anti-platelet therapy is completed, after one year. Over the course of the study patients will be followed up for data collection about cardiac health events such as heart attack, stroke, severe, recurrent reduced blood flow (ischemia), death and blood clots from the stent (stent thrombosis). The cardiac health events or endpoints will be assessed and compared between the three different groups in the study.

The purpose of the study is to see if genetic testing can identify the best anti-platelet therapy, for patients who undergo a coronary stent placement and who do not activate Clopidogrel very well because of the CYP2C19 liver enzyme abnormality.

IRB Number   15018
Inclusion/Notes   Patients with an acute coronary syndrome (ACS), who are eligible for PCI. ACS is a problem that occurs when there isn’t enough blood flow to the heart. Heart attack and unstable angina (sudden chest pain that usually occurs when someone is at rest) are two examples.
Principal Name   Kevin Marzo, MD
Contact Name   Wendy Drewes, BSN, RN, CCRC (wdrewes@nyuwinthrop.org)
Email   kmarzo@nyuwinthrop.org
Phone   516-663-2396
Alternate Phone   516-663-2929