ASpirin vs Triflusal for Event Reduction In Atherothrombosis Secondary Prevention (ASTERIAS)

NCT02616497 | Completed Phase 4

• 1 other identifier: Asp-Trifl-1
• Study Type: interventional
• Target: 1,220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherothrombosis

Keywords

aspirin; triflusal; antiplatelet drugs; atherothrombosis; secondary prevention; bleeding

Outcome Measures

Primary Outcomes (2)

• Composite of death from vascular causes, myocardial infarction (MI), or stroke (ischaemic or haemorrhagic) during the twelve month treatment period

  Number of participants who suffer from the primary efficacy end point which is the composite of death from vascular causes, myocardial infarction(MI), or stroke during the twelve month treatment period

  12 months

• Rate of bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria during the twelve month treatment period

  Number of participants who suffer from the rate of bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria during the twelve month treatment period

  12 months

Secondary Outcomes (2)

• Composite of death from any cause, MI, or stroke during the twelve month treatment period

  12 months

• Hypersensitivity or intolerance to study drugs during the twelve month treatment period

  12 months

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

100mg/day

Drug: Aspirin

Triflusal

ACTIVE COMPARATOR

300mg twice or 600mg once daily

Drug: Triflusal

Interventions

Aspirin DRUG

COX-1 inhibitor

Also known as: Salospir

Aspirin

Triflusal DRUG

COX-1 inhibitor

Also known as: Aflen

Triflusal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a stable coronary artery disease (CAD)
• Patients with a history of non-cardioembolic ischemic stroke.

You may not qualify if:

• Hypersensitivity reaction or contraindication to triflusal or aspirin
• Active bleeding or history of severe bleeding (peptic ulcer, trauma or intracranial hemorrhage)
• Blood coagulation disorders
• Uncontrolled severe hypertension
• Pregnancy or breastfeeding
• Liver disease (alanine or aspartate aminotransferase more than 3 times the upper normal limit)
• Malignancy that may potentially increase the risk of hemorrhage
• Drug or alcohol abuse
• HIV infection
• Chronic disorders requiring long-term treatment with systemic nonsteroidal anti-inflammatory drugs (NSAIDs).

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina

Ioannina, 45110, Greece

Location

Related Publications (21)

• 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.

  PMID: 21745731 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.

  PMID: 19067731 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.

  PMID: 19465361 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.

  PMID: 15711832 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.

  PMID: 21327422 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.

  PMID: 20118963 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.

  PMID: 11786451 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.

  PMID: 18202034 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.

  PMID: 17698681 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.

  PMID: 21035882 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.

  PMID: 19100419 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.

  PMID: 18928790 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.

  PMID: 18196658 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.

  PMID: 22697594 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.

  PMID: 16620146 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.

  PMID: 12649515 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.

  PMID: 15079004 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.

  PMID: 10681486 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.

  PMID: 16034926 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.

  PMID: 15489085 BACKGROUND

• 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.

  PMID: 29866011 DERIVED

MeSH Terms

Conditions

Thrombosis; Hemorrhage

Interventions

Aspirin; triflusal

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Alexandros Tselepis, MD

  Atherothrombosis Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biochemistry and Clinical Chemistry

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 30, 2015
• Study Start: September 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: March 28, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

GR (1)