TY - JOUR
T1 - Rationale and design of the Hunting for the off-target propertIes of Ticagrelor on Endothelial function and other Circulating biomarkers in Humans (HI-TECH) trial
AU - Ariotti, Sara
AU - van Leeuwen, Maarten
AU - Brugaletta, Salvatore
AU - Leonardi, Sergio
AU - Akkerhuis, Kristiaan Martijn
AU - Rexhaj, Emrush
AU - Janssens, Gladys
AU - Ortega-Paz, Luis
AU - Rizzotti, Diego
AU - van den Berge, Jan C.
AU - Heg, Dierik
AU - Francolini, Gloria
AU - Windecker, Stephan
AU - Valgimigli, Marco
AU - The HI-TECH Investigators
PY - 2017/7/1
Y1 - 2017/7/1
N2 - Background Among the 3 approved oral P2Y12 inhibitors for the treatment for patients with acute coronary syndrome (ACS), ticagrelor, but not prasugrel or clopidogrel, has been associated with off-target properties, such as improved endothelial-dependent vasomotion and increased adenosine plasma levels. Methods The HI-TECH study (NCT02587260) is a multinational, randomized, open-label, crossover study with a Latin squares design, conducted at 5 European sites, in which patients free from recurrent ischemic or bleeding events ≥30 days after a qualifying ACS were allocated to sequentially receive a 30 ± 5-day treatment with prasugrel, clopidogrel, and ticagrelor in random order. The primary objective was to evaluate whether ticagrelor, at treatment steady state (ie, after 30 ± 5 days of drug administration), as compared with both clopidogrel and prasugrel, is associated with an improved endothelial function, assessed with peripheral arterial tonometry. Thirty-six patients undergoing evaluable endothelial function assessment for each of the assigned P2Y12 inhibitor were needed to provide 90% power to detect a 10% relative change of the reactive hyperemia index in the ticagrelor group. Conclusion The HI-TECH study is the first randomized, crossover study aiming to ascertain whether ticagrelor, when administered at approved regimen in post-ACS patients, improves endothelial function as compared with both clopidogrel and prasugrel.
AB - Background Among the 3 approved oral P2Y12 inhibitors for the treatment for patients with acute coronary syndrome (ACS), ticagrelor, but not prasugrel or clopidogrel, has been associated with off-target properties, such as improved endothelial-dependent vasomotion and increased adenosine plasma levels. Methods The HI-TECH study (NCT02587260) is a multinational, randomized, open-label, crossover study with a Latin squares design, conducted at 5 European sites, in which patients free from recurrent ischemic or bleeding events ≥30 days after a qualifying ACS were allocated to sequentially receive a 30 ± 5-day treatment with prasugrel, clopidogrel, and ticagrelor in random order. The primary objective was to evaluate whether ticagrelor, at treatment steady state (ie, after 30 ± 5 days of drug administration), as compared with both clopidogrel and prasugrel, is associated with an improved endothelial function, assessed with peripheral arterial tonometry. Thirty-six patients undergoing evaluable endothelial function assessment for each of the assigned P2Y12 inhibitor were needed to provide 90% power to detect a 10% relative change of the reactive hyperemia index in the ticagrelor group. Conclusion The HI-TECH study is the first randomized, crossover study aiming to ascertain whether ticagrelor, when administered at approved regimen in post-ACS patients, improves endothelial function as compared with both clopidogrel and prasugrel.
UR - http://www.scopus.com/inward/record.url?scp=85018454471&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2017.03.017
DO - 10.1016/j.ahj.2017.03.017
M3 - Article
C2 - 28625369
AN - SCOPUS:85018454471
VL - 189
SP - 128
EP - 136
JO - The American Heart Journal
JF - The American Heart Journal
SN - 0002-8703
ER -