The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent
Cristina Lucía Dávila-Fajardo,
Jesús Sánchez-Ramos,
Xando Diaz- Villamarín,
Luis Javier Martínez-González,
Pablo Toledo Frías,
Susana Martínez Huertas,
Francisco Burillo Gómez,
Juan Caballero Borrego,
Alicia Bautista Pavés,
Mª Carmen Marín Guzmán,
José Antonio Ramirez Hernández,
Concepción Correa Vilches,
Jose Cabeza Barrera
Affiliations
Cristina Lucía Dávila-Fajardo
Department of Clinical Pharmacy, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
Jesús Sánchez-Ramos
Department of Cardiology, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
Xando Diaz- Villamarín
Department of Clinical Pharmacy, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
Luis Javier Martínez-González
Genomics Unit, Centre for Genomics and Oncological Research (GENYO), Pfizer-University of Granada-Andalusian Regional Government, Health Sciences Technology Park, Granada, Spain
Pablo Toledo Frías
Department of Cardiology, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
Susana Martínez Huertas
Department of Cardiology, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
Francisco Burillo Gómez
Department of Cardiology, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
Juan Caballero Borrego
Department of Cardiology, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
Alicia Bautista Pavés
Department of Cardiology, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
Mª Carmen Marín Guzmán
Department of Cardiology, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
José Antonio Ramirez Hernández
Department of Clinical Pharmacy, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
Concepción Correa Vilches
Department of Cardiology, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
Jose Cabeza Barrera
Department of Clinical Pharmacy, Granada University Hospital, Institute for Biomedical Research, ibs., Granada, Spain
This article contains data related to the research article entitled “Results of genotype–guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent” (J. Sánchez-Ramos, C.L. Dávila-Fajardo, P. Toledo Frías, X. Díaz Villamarín, L.J. Martínez-González, S. Martínez Huertas, F. Burillo Gómez, J. Caballero Borrego, A. Bautista Pavés, M.C. Marín Guzmán, J.A. Ramirez Hernández, C. Correa Vilches, J. Cabeza Barrera, 2016) (1). This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype–guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI) with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up), study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33).
