REsistance to Aspirin and Clopidogrel in acuTe Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare 3 point-of-care methods for monitoring antiplatelet
      therapy to golden standard (Light transmittance aggregometry-LTA) in high risk population of
      acute myocardial infarction patients. If two methods (PFA-100, VerifyNOW,Multiplate or LTA)
      will indicate insufficient antiplatelet blockade/high residual reactivity for aspirin,
      clopidogrel or both, the dose of aspirin will be increased to 200mg qd and the dose of
      clopidogrel will be increased to 2x75mg qd.In addition genotyping of CYP2C19 (6 alleles) will
      be performed.
    

Detailed description: 
      Dual antiplatelet therapy is the cornerstone of treatment of coronary heart disease after
      coronary stent implantation. The interindividual response to this therapy is not uniform,
      however. There are subgroups of patients, where no anticipated antiplatelet effect to either
      aspirin, clopidogrel or both is reached. The term of aspirin/clopidogrel resistance has been
      introduced few years ago, most recently it was substituted by more suitable term - high
      on-treatment residual platelet reactivity (HPR). Although there are many assays to monitor
      antiplatelet therapy, uncertainty still remains about the correlation of HPR with ischemic
      vascular events (in-stent thrombosis, myocardial infarction, etc.). Thus platelet aggregation
      testing is considered to be the most promising method to indicate inappropriate/low response
      to aspirin/clopidogrel, however the best suited method is not established yet. Up-to date
      light transmittance aggregometry is widely accepted as golden standard, nonetheless labour
      intensive and difficult to standardize. On the other hand many point-of-care aggregation
      testing methods like PFA-100, VerifyNOW, Multiplate etc. have been introduced, their role in
      clinical practice is uncertain, however. The biggest challenge of today is to determine
      platelet function assay, which could reliably indicate future ischemic vascular
      events;moreover it could be potentially used to tailor antiplatelet therapy and precede these
      events. It was demonstrated, that gene polymorphism - CYP2C19*2 and CYP2C9*3 loss of function
      is conjugated with an increased occurrence of stent thrombosis. Within the project we also
      plan to examine 4 alleles which have not been examined in detail before.
    

Intervention name(s): Aspirin 200mg qd, Clopidogrel 2x75mg qd
Intervention type(s): Drug
Intervention description(s): According to 2 platelet monitoring assays HPR confirmation aspirin will be increased to 200mg qd, clopidogrel to 2x75mg qd. This treatment will be given for 30 days from index event (myocardial infarction)
Other intervention name(s): R-130964
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: myocardial infarction; percutaneous coronary intervention (PCI); high platelet reactivity (HPR)