title: Study design and rationale for Optimal aNtiplatelet pharmacotherapy guided by bedSIDE genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST): a prospective, open-label, randomised parallel-group multicentre trial (NCT01930773).
abstract: OBJECTIVE
  High platelet reactivity (HPR) and presence of CYP2C19 loss-of-function alleles are associated with higher risk for periprocedural myocardial infarction in clopidogrel-treated patients undergoing percutaneous coronary intervention (PCI). It is unknown whether personalised treatment based on platelet function testing or genotyping can prevent such complications.
  
  
  METHODS
  The ONSIDE-TEST is a multicentre, prospective, open-label, randomised controlled clinical trial aiming to assess if optimisation of antiplatelet therapy based on either phenotyping or genotyping is superior to conventional care. Patients will be randomised into phenotyping, genotyping, or control arms. In the phenotyping group, patients will be tested with the VerifyNow P2Y12 assay before PCI, and patients with a platelet reactivity unit greater than 208 will be switched over to prasugrel, while others will continue on clopidogrel therapy. In the genotyping group, carriers of the *2 loss-of-function allele will receive prasugrel for PCI, while wild-type subjects will be treated with clopidogrel. Patients in the control arm will be treated with standard-dose clopidogrel. The primary endpoint of the study is the prevalence of periprocedural myocardial injury within 24 h after PCI in the controls as compared to the phenotyping and genotyping group. Secondary endpoints include cardiac death, myocardial infarction, definite or probable stent thrombosis, or urgent repeat revascularisation within 30 days of PCI. Primary safety outcome is Bleeding Academic Research Consortium (BARC) type 3 and 5 bleeding during 30 days of PCI.
  
  
  CONCLUSIONS
  The ONSIDE TEST trial is expected to verify the clinical utility of an individualised antiplatelet strategy in preventing periprocedural myocardial injury by either phenotyping or genotyping.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01930773.
authors.affiliation: 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland. lukasz@koltowski.com.
authors.forename: Łukasz
authors.initials: Ł
authors.lastname: Kołtowski
authors.forename: Daniel
authors.initials: D
authors.lastname: Aradi
authors.forename: Zenon
authors.initials: Z
authors.lastname: Huczek
authors.forename: Mariusz
authors.initials: M
authors.lastname: Tomaniak
authors.forename: Dirk
authors.initials: D
authors.lastname: Sibbing
authors.forename: Krzysztof J
authors.initials: KJ
authors.lastname: Filipiak
authors.forename: Janusz
authors.initials: J
authors.lastname: Kochman
authors.forename: Paweł
authors.initials: P
authors.lastname: Balsam
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Opolski
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000077144:Clopidogrel; D065731:Cytochrome P-450 CYP2C19 / Q000235:genetics*; D006801:Humans; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000209:etiology* / Q000378:metabolism / Q000517:prevention & control; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D000071185:Pharmacogenomic Testing; D000071184:Pharmacogenomic Variants; D010975:Platelet Aggregation Inhibitors / Q000378:metabolism / Q000627:therapeutic use*; D010979:Platelet Function Tests; D000068799:Prasugrel Hydrochloride / Q000378:metabolism / Q000627:therapeutic use; D011446:Prospective Studies; D012107:Research Design; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000378:metabolism / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D065731:Cytochrome P-450 CYP2C19; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine
keywords: CYP2C19*2 allele polymorphism; antiplatelet therapy; bedside testing; clopidogrel; high platelet reactivity; percutaneous coronary interventions; prasugrel; stable coronary artery disease