Clopidogrel Platelet Function Tests

FDA Answer

December 2011

The FDA replied that they were not making any recommendation concerning the use of genetic testing; they were only informing health care professionals that such genetic testing is available to identify CYP2C19 polymorphisms and were leaving genetic testing decisions up to the practitioner’s professional judgment.

< Previous Slide

FDA Answer

Next Slide >

 

Jump to section:

• Introduction
• Learning Objectives
• Platelet Function Tests for the Detection of Clopidogrel Resistance¹
• Platelet Function Tests for the Detection of Clopidogrel Resistance
• Caveat: There Is No Perfect Platelet Function Test...
• Problems With Testing For Clopidogrel
• How We Choose a Testing Method
• Methodology Table
• Platelet Function Testing Available at Mayo Clinic Florida
• Light Transmission Platelet Aggregometry Studies (LTA)
• Platelet Aggregation (Cont'd)
• Normal Patient
• Accumetrics VerifyNow Test
• VerifyNow P2Y₁₂ Test
• P2Y₁₂ Test Interferences
• P2Y₁₂ Antagonists²
• Can These Platelet Function Tests Be Used for Ticagrelor (Brilinta/Brilique)?
• PFA-100
• PFA–100 (Cont'd)
• INNOVANCE PFA P2Y
• TEG — Platelet Mapping
• Results of VerifyNow Testing
• 2009–2011 Clopidogrel Response at 30%
• Genetic Testing: Clopidogrel Metabolism
• Clopidogrel Metabolism
• Number of Gene Polymorphisms
• Clopidogrel Metabolism and Genetic Polymorphisms
• Why Do Genetic Testing?
• Clopidogrel Genetics (Cont'd)
• Caveats — Other Reasons for Poor Response to Clopidogrel
• CYP2C19 Polymorphism May Require Another Factor
• Controversy for Clopidogrel
• Warning: Diminished Effectiveness In Poor Metabolizers
• What Does Warning Mean For Clinicians With Patients On Clopidogrel?
• FDA Answer
• More Questions
• Summary
• References
• Questions?
• Disclosure