drugset / Trial / NCT02587260
Hunting for the Off-Target Properties of Ticagrelor on Endothelial Function in Humans (HI-TECH)
RandomizedCrossoverSingle-blindTreatment
Summary
The purpose of this randomized, cross-over study, is to ascertain if ticagrelor, but not prasugrel or clopidogrel, is associated to an improved endothelial function as assessed with peripheral arterial tonometry and markers of endothelial function measurement in post-ACS patients.
Timeline
- Start
- 2015-12-17
- Primary completion
- 2017-02-10
- Completion
- 2017-02-10
Publications
- Background Hochberg Y, Benjamini Y. More powerful procedures for multiple significance testing. Stat Med. 1990 Jul;9(7):811-8. doi: 10.1002/sim.4780090710.
- Results Flammer AJ, Anderson T, Celermajer DS, Creager MA, Deanfield J, Ganz P, Hamburg NM, Luscher TF, Shechter M, Taddei S, Vita JA, Lerman A. The assessment of endothelial function: from research into clinical practice. Circulation. 2012 Aug 7;126(6):753-67. doi: 10.1161/CIRCULATIONAHA.112.093245.
- Results Cattaneo M, Schulz R, Nylander S. Adenosine-mediated effects of ticagrelor: evidence and potential clinical relevance. J Am Coll Cardiol. 2014 Jun 17;63(23):2503-2509. doi: 10.1016/j.jacc.2014.03.031. Epub 2014 Apr 23.
- Results Bonello L, Laine M, Kipson N, Mancini J, Helal O, Fromonot J, Gariboldi V, Condo J, Thuny F, Frere C, Camoin-Jau L, Paganelli F, Dignat-George F, Guieu R. Ticagrelor increases adenosine plasma concentration in patients with an acute coronary syndrome. J Am Coll Cardiol. 2014 Mar 11;63(9):872-7. doi: 10.1016/j.jacc.2013.09.067. Epub 2013 Nov 27.
- Results Torngren K, Ohman J, Salmi H, Larsson J, Erlinge D. Ticagrelor improves peripheral arterial function in patients with a previous acute coronary syndrome. Cardiology. 2013;124(4):252-8. doi: 10.1159/000347122. Epub 2013 Apr 9.
- Results McCrea CE, Skulas-Ray AC, Chow M, West SG. Test-retest reliability of pulse amplitude tonometry measures of vascular endothelial function: implications for clinical trial design. Vasc Med. 2012 Feb;17(1):29-36. doi: 10.1177/1358863X11433188.
- Ariotti S, Ortega-Paz L, van Leeuwen M, Brugaletta S, Leonardi S, Akkerhuis KM, Rimoldi SF, Janssens G, Gianni U, van den Berge JC, Karagiannis A, Windecker S, Valgimigli M; HI-TECH Investigators. Effects of Ticagrelor, Prasugrel, or Clopidogrel on Endothelial Function and Other Vascular Biomarkers: A Randomized Crossover Study. JACC Cardiovasc Interv. 2018 Aug 27;11(16):1576-1586. doi: 10.1016/j.jcin.2018.04.022. Epub 2018 May 24.
- Ariotti S, van Leeuwen M, Brugaletta S, Leonardi S, Akkerhuis KM, Rimoldi SF, Janssens GN, Ortega-Paz L, Gianni U, van den Berge JC, Karagiannis A, Windecker S, Valgimigli M; HI-TECH Investigators. Effects of Ticagrelor, Prasugrel, or Clopidogrel at Steady State on Endothelial Function. J Am Coll Cardiol. 2018 Mar 20;71(11):1289-1291. doi: 10.1016/j.jacc.2018.01.027. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clopidogrel | Small molecule | 75 mg | Oral |
| Comparator | Prasugrel | Small molecule | 5 mg | Oral |
| Comparator | Prasugrel | Small molecule | 10 mg | Oral |
| Comparator | Ticagrelor | Small molecule | 90 mg | Oral |