drugset / Trial / NCT02616497
ASpirin vs Triflusal for Event Reduction In Atherothrombosis Secondary Prevention (ASTERIAS)
RandomizedParallel-groupOpen-labelHealth-services research
Summary
Investigation of the efficacy and safety of triflusal in comparison with aspirin in patients with stable coronary artery disease (CAD) and in those with a history of an acute non-cardioembolic ischemic stroke.
Timeline
- Start
- 2015-09
- Primary completion
- 2017-02-28
- Completion
- 2018-03-28
Publications
- Background Di Minno G. Aspirin resistance and platelet turnover: a 25-year old issue. Nutr Metab Cardiovasc Dis. 2011 Aug;21(8):542-5. doi: 10.1016/j.numecd.2011.04.002. Epub 2011 Jul 13.
- Background Feher G, Feher A, Pusch G, Lupkovics G, Szapary L, Papp E. The genetics of antiplatelet drug resistance. Clin Genet. 2009 Jan;75(1):1-18. doi: 10.1111/j.1399-0004.2008.01105.x. Epub 2008 Nov 29.
- Background Anninos H, Andrikopoulos G, Pastromas S, Sakellariou D, Theodorakis G, Vardas P. Triflusal: an old drug in modern antiplatelet therapy. Review of its action, use, safety and effectiveness. Hellenic J Cardiol. 2009 May-Jun;50(3):199-207. No abstract available.
- Background Valle M, Barbanoj MJ, Donner A, Izquierdo I, Herranz U, Klein N, Eichler HG, Muller M, Brunner M. Access of HTB, main metabolite of triflusal, to cerebrospinal fluid in healthy volunteers. Eur J Clin Pharmacol. 2005 Apr;61(2):103-11. doi: 10.1007/s00228-004-0887-0. Epub 2005 Feb 12.
- Background Antonijoan RM, Gich I, Azaro A, Sainz S, Balanzo J, Izquierdo I, Borja J, Donado E, Blanch I, Barbanoj MJ. Gastrointestinal safety of triflusal solution in healthy volunteers: a proof of concept endoscopic study. Eur J Clin Pharmacol. 2011 Jul;67(7):663-9. doi: 10.1007/s00228-011-1004-9. Epub 2011 Feb 16.
- Background Michelson AD. Antiplatelet therapies for the treatment of cardiovascular disease. Nat Rev Drug Discov. 2010 Feb;9(2):154-69. doi: 10.1038/nrd2957.
- Background Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71.
- Background Krasopoulos G, Brister SJ, Beattie WS, Buchanan MR. Aspirin "resistance" and risk of cardiovascular morbidity: systematic review and meta-analysis. BMJ. 2008 Jan 26;336(7637):195-8. doi: 10.1136/bmj.39430.529549.BE. Epub 2008 Jan 17.
- Background Snoep JD, Hovens MM, Eikenboom JC, van der Bom JG, Huisman MV. Association of laboratory-defined aspirin resistance with a higher risk of recurrent cardiovascular events: a systematic review and meta-analysis. Arch Intern Med. 2007 Aug 13-27;167(15):1593-9. doi: 10.1001/archinte.167.15.1593.
- Background Undas A, Siudak Z, Topor-Madry R, Lesniak M, Tracz W. Simvastatin administration reduces thromboxane production in subjects taking aspirin: links between aspirin resistance and thrombin generation. Int J Cardiol. 2012 Jan 12;154(1):59-64. doi: 10.1016/j.ijcard.2010.09.093. Epub 2010 Oct 29.
- Background Acikel S, Yildirir A, Aydinalp A, Demirtas K, Bal U, Kaynar G, Ozin B, Karakayali H, Muderrisoglu H, Haberal M. Incidence of aspirin resistance and its relationship with cardiovascular risk factors and graft function in renal transplant recipients. Transplant Proc. 2008 Dec;40(10):3485-8. doi: 10.1016/j.transproceed.2008.06.108.
- Background Simon DI, Jozic J. Drug-eluting stents and antiplatelet resistance. Am J Cardiol. 2008 Nov 3;102(9 Suppl):29J-37J. doi: 10.1016/j.amjcard.2008.09.007.
- Background Papathanasiou A, Goudevenos J, Tselepis AD. Resistance to aspirin and clopidogrel: possible mechanisms, laboratory investigation, and clinical significance. Hellenic J Cardiol. 2007 Nov-Dec;48(6):352-63. No abstract available.
- Background Kalantzi KI, Tsoumani ME, Goudevenos IA, Tselepis AD. Pharmacodynamic properties of antiplatelet agents: current knowledge and future perspectives. Expert Rev Clin Pharmacol. 2012 May;5(3):319-36. doi: 10.1586/ecp.12.19.
- Background Murdoch D, Plosker GL. Triflusal: a review of its use in cerebral infarction and myocardial infarction, and as thromboprophylaxis in atrial fibrillation. Drugs. 2006;66(5):671-92. doi: 10.2165/00003495-200666050-00009.
- Background Matias-Guiu J, Ferro JM, Alvarez-Sabin J, Torres F, Jimenez MD, Lago A, Melo T; TACIP Investigators. Comparison of triflusal and aspirin for prevention of vascular events in patients after cerebral infarction: the TACIP Study: a randomized, double-blind, multicenter trial. Stroke. 2003 Apr;34(4):840-8. doi: 10.1161/01.STR.0000063141.24491.50. Epub 2003 Mar 20.
- Background Culebras A, Rotta-Escalante R, Vila J, Dominguez R, Abiusi G, Famulari A, Rey R, Bauso-Tosselli L, Gori H, Ferrari J, Reich E; TAPIRSS investigators. Triflusal vs aspirin for prevention of cerebral infarction: a randomized stroke study. Neurology. 2004 Apr 13;62(7):1073-80. doi: 10.1212/01.wnl.0000113757.34662.aa.
- Background Cruz-Fernandez JM, Lopez-Bescos L, Garcia-Dorado D, Lopez Garcia-Aranda V, Cabades A, Martin-Jadraque L, Velasco JA, Castro-Beiras A, Torres F, Marfil F, Navarro E. Randomized comparative trial of triflusal and aspirin following acute myocardial infarction. Eur Heart J. 2000 Mar;21(6):457-65. doi: 10.1053/euhj.1999.1874.
- Background Costa J, Ferro JM, Matias-Guiu J, Alvarez-Sabin J, Torres F. Triflusal for preventing serious vascular events in people at high risk. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD004296. doi: 10.1002/14651858.CD004296.pub2.
- Background Perez-Gomez F, Alegria E, Berjon J, Iriarte JA, Zumalde J, Salvador A, Mataix L; NASPEAF Investigators. Comparative effects of antiplatelet, anticoagulant, or combined therapy in patients with valvular and nonvalvular atrial fibrillation: a randomized multicenter study. J Am Coll Cardiol. 2004 Oct 19;44(8):1557-66. doi: 10.1016/j.jacc.2004.05.084.
- Kalantzi KI, Ntalas IV, Chantzichristos VG, Tsoumani ME, Adamopoulos D, Asimakopoulos C, Bourdakis A, Darmanis P, Dimitriadou A, Gkiokas S, Ipeirotis K, Kitikidou K, Klonaris I, Kostaki A, Logothetis D, Mainas K, Mais T, Maragiannis A, Martiadou K, Mavronasos K, Michelongonas I, Mitropoulos D, Papadimitriou G, Papadopoulos A, Papaioakeim M, Sofillas K, Stabola S, Stefanakis E, Stergiou D, Thoma M, Zenetos A, Zisekas S, Goudevenos JA, Panagiotakos DB, Tselepis AD. Comparison of Triflusal with Aspirin in the Secondary Prevention of Atherothrombotic Events; Alpha Randomised Clinical Trial. Curr Vasc Pharmacol. 2019;17(6):635-643. doi: 10.2174/1570161116666180605090520.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 100 mg | — |
| Comparator | Triflusal | Small molecule | 300 mg | Oral |
| Comparator | Triflusal | Small molecule | 600 mg | Oral |