Clinical trial NCT06129526 - References

Diabetes Mellitus — Study of the Efficacy and Safety of EPA in Patients With Type-2 Diabetes

Citation(s)

•   ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, Stevens W, Buck G, Barton J, Murphy K, Aung T, Haynes R, Cox J, Murawska A, Young A, Lay M, Chen F, Sammons E, Waters E, Adler A, Bodansky J, Farmer A, McPherson R, Neil A, Simpson D, Peto R, Baigent C, Collins R, Parish S, Armitage J
  Effects of n-3 Fatty Acid Supplements in Diabetes Mellitus. N Engl J Med. 2018 Oct 18;379(16):1540-1550. doi: 10.1056/NEJMoa1804989. Epub 2018 Aug 26.
•   Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators
  Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10.
•   Budoff MJ, Bhatt DL, Kinninger A, Lakshmanan S, Muhlestein JB, Le VT, May HT, Shaikh K, Shekar C, Roy SK, Tayek J, Nelson JR
  Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial. Eur Heart J. 2020 Oct 21;41(40):3925-3932. doi: 10.1093/eurheartj/ehaa652.
•   Calder PC
  Mechanisms of action of (n-3) fatty acids. J Nutr. 2012 Mar;142(3):592S-599S. doi: 10.3945/jn.111.155259. Epub 2012 Jan 25.
•   Cholewski M, Tomczykowa M, Tomczyk M
  A Comprehensive Review of Chemistry, Sources and Bioavailability of Omega-3 Fatty Acids. Nutrients. 2018 Nov 4;10(11):1662. doi: 10.3390/nu10111662.
•   de Carvalho CCCR, Caramujo MJ
  The Various Roles of Fatty Acids. Molecules. 2018 Oct 9;23(10):2583. doi: 10.3390/molecules23102583.
•   Fialkow J
  Omega-3 Fatty Acid Formulations in Cardiovascular Disease: Dietary Supplements are Not Substitutes for Prescription Products. Am J Cardiovasc Drugs. 2016 Aug;16(4):229-239. doi: 10.1007/s40256-016-0170-7.
•   Goel A, Pothineni NV, Singhal M, Paydak H, Saldeen T, Mehta JL
  Fish, Fish Oils and Cardioprotection: Promise or Fish Tale? Int J Mol Sci. 2018 Nov 22;19(12):3703. doi: 10.3390/ijms19123703.
•   Grayling MJ, Mander AP, Wason JMS
  Blinded and unblinded sample size reestimation in crossover trials balanced for period. Biom J. 2018 Sep;60(5):917-933. doi: 10.1002/bimj.201700092. Epub 2018 Aug 3.
•   Harden M, Friede T
  Sample size calculation in multi-centre clinical trials. BMC Med Res Methodol. 2018 Nov 29;18(1):156. doi: 10.1186/s12874-018-0602-y.
•   Innes JK, Calder PC
  Marine Omega-3 (N-3) Fatty Acids for Cardiovascular Health: An Update for 2020. Int J Mol Sci. 2020 Feb 18;21(4):1362. doi: 10.3390/ijms21041362.
•   Kalantzi K, Tentolouris N, Melidonis AJ, Papadaki S, Peroulis M, Amantos KA, Andreopoulos G, Bellos GI, Boutel D, Bristianou M, Chrisis D, Dimitsikoglou NA, Doupis J, Georgopoulou C, Gkintikas SA, Iraklianou S, Kanellas Kappa, Kotsa K, Koufakis T, Kouroglou M, Koutsovasilis AG, Lanaras L, Liouri E, Lixouriotis C, Lykoudi A, Mandalaki E, Papageorgiou E, Papanas N, Rigas S, Stamatelatou MI, Triantafyllidis I, Trikkalinou A, Tsouka AN, Zacharopoulou O, Zoupas C, Tsolakis I, Tselepis AD
  Efficacy and Safety of Adjunctive Cilostazol to Clopidogrel-Treated Diabetic Patients With Symptomatic Lower Extremity Artery Disease in the Prevention of Ischemic Vascular Events. J Am Heart Assoc. 2021 Jan 5;10(1):e018184. doi: 10.1161/JAHA.120.018184. Epub 2020 Dec 17.
•   Kromhout D, Giltay EJ, Geleijnse JM; Alpha Omega Trial Group
  n-3 fatty acids and cardiovascular events after myocardial infarction. N Engl J Med. 2010 Nov 18;363(21):2015-26. doi: 10.1056/NEJMoa1003603. Epub 2010 Aug 28.
•   Liu Y, Xu H
  Sample size re-estimation for pivotal clinical trials. Contemp Clin Trials. 2021 Mar;102:106215. doi: 10.1016/j.cct.2020.106215. Epub 2020 Nov 18.
•   Maki KC, Johns C, Harris WS, Puder M, Freedman SD, Thorsteinsson T, Daak A, Rabinowicz AL, Sancilio FD
  Bioequivalence Demonstration for Omega-3 Acid Ethyl Ester Formulations: Rationale for Modification of Current Guidance. Clin Ther. 2017 Mar;39(3):652-658. doi: 10.1016/j.clinthera.2017.01.019. Epub 2017 Feb 8.
•   Manson JE, Cook NR, Lee IM, Christen W, Bassuk SS, Mora S, Gibson H, Albert CM, Gordon D, Copeland T, D'Agostino D, Friedenberg G, Ridge C, Bubes V, Giovannucci EL, Willett WC, Buring JE; VITAL Research Group
  Marine n-3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer. N Engl J Med. 2019 Jan 3;380(1):23-32. doi: 10.1056/NEJMoa1811403. Epub 2018 Nov 10.
•   Nicholls SJ, Lincoff AM, Garcia M, Bash D, Ballantyne CM, Barter PJ, Davidson MH, Kastelein JJP, Koenig W, McGuire DK, Mozaffarian D, Ridker PM, Ray KK, Katona BG, Himmelmann A, Loss LE, Rensfeldt M, Lundstrom T, Agrawal R, Menon V, Wolski K, Nissen SE
  Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial. JAMA. 2020 Dec 8;324(22):2268-2280. doi: 10.1001/jama.2020.22258.
•   Ntalas IV, Kalantzi KI, Tsoumani ME, Bourdakis A, Charmpas C, Christogiannis Z, Dimoulis N, Draganigos A, Efthimiadis I, Giannakoulas G, Giatrakos I, Giogiakas V, Goumas G, Hatziathanasiou G, Kazakos E, Kipouridis N, Konstantinou S, Milionis H, Nikolopoulos D, Peltekis L, Prokopakis N, Sinteles I, Stroumbis C, Terzoudi K, Thoma M, Tsilias K, Vakalis I, Vardakis K, Vasilakopoulos V, Vemmos K, Voukelatou M, Xaraktsis I, Panagiotakos DB, Goudevenos JA, Tselepis AD
  Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial. J Cardiovasc Pharmacol Ther. 2016 Nov;21(6):516-525. doi: 10.1177/1074248416644343. Epub 2016 Apr 14.
•   Ntalas IV, Kalantzi KI, Tsoumani ME, Vakalis JN, Vasilakopoulos V, Vardakis K, Vemmos KN, Voukelatou M, Giannakoulas G, Giatrakos I, Giogiakas V, Goumas G, Dimoulis N, Draganigos A, Efthimiadis I, Thoma M, Kazakos E, Kipouridis N, Konstantinou S, Bourdakis A, Nikolopoulos D, Peltekis L, Prokopakis N, Sinteles I, Stroumbis CS, Terzoudi K, Tsilias K, Xaraktsis I, Charmpas C, Hatziathanasiou G, Christogiannis Z, Panagiotakos DB, Goudevenos JA, Tselepis AD
  Generic Clopidogrel Besylate in the Secondary Prevention of Atherothrombotic Events: A 6-month Follow-up of a Randomised Clinical Trial. Curr Vasc Pharmacol. 2015;13(6):809-18. doi: 10.2174/1570161113666150316220515.
•   Preston Mason R
  New Insights into Mechanisms of Action for Omega-3 Fatty Acids in Atherothrombotic Cardiovascular Disease. Curr Atheroscler Rep. 2019 Jan 12;21(1):2. doi: 10.1007/s11883-019-0762-1.
•   Ryan, Thomas P
  2013. Sample Size Determination and Power. John Wiley & Sons. New Jersey.
•   Sherratt SCR, Juliano RA, Mason RP
  Eicosapentaenoic acid (EPA) has optimal chain length and degree of unsaturation to inhibit oxidation of small dense LDL and membrane cholesterol domains as compared to related fatty acids in vitro. Biochim Biophys Acta Biomembr. 2020 Jul 1;1862(7):183254. doi: 10.1016/j.bbamem.2020.183254. Epub 2020 Mar 2.
•   Shibabaw T
  Omega-3 polyunsaturated fatty acids: anti-inflammatory and anti-hypertriglyceridemia mechanisms in cardiovascular disease. Mol Cell Biochem. 2021 Feb;476(2):993-1003. doi: 10.1007/s11010-020-03965-7. Epub 2020 Nov 11.
•   Tsoumani ME, Kalantzi KI, Dimitriou AA, Ntalas IV, Goudevenos IA, Tselepis AD
  Antiplatelet efficacy of long-term treatment with clopidogrel besylate in patients with a history of acute coronary syndrome: comparison with clopidogrel hydrogen sulfate. Angiology. 2012 Oct;63(7):547-51. doi: 10.1177/0003319711427697. Epub 2011 Dec 5.
•   Tsoumani ME, Kalantzi KI, Dimitriou AA, Ntalas IV, Goudevenos IA, Tselepis AD
  Effect of clopidogrel besylate on platelet reactivity in patients with acute coronary syndromes. Comparison with clopidogrel hydrogen sulfate. Expert Opin Pharmacother. 2012 Feb;13(2):149-58. doi: 10.1517/14656566.2012.644536. Epub 2011 Dec 21.
•   Wang P, Chow SC
  Sample size re-estimation in clinical trials. Stat Med. 2021 Nov 30;40(27):6133-6149. doi: 10.1002/sim.9175. Epub 2021 Aug 25.
•   Watanabe T, Ando K, Daidoji H, Otaki Y, Sugawara S, Matsui M, Ikeno E, Hirono O, Miyawaki H, Yashiro Y, Nishiyama S, Arimoto T, Takahashi H, Shishido T, Miyashita T, Miyamoto T, Kubota I; CHERRY study investigators
  A randomized controlled trial of eicosapentaenoic acid in patients with coronary heart disease on statins. J Cardiol. 2017 Dec;70(6):537-544. doi: 10.1016/j.jjcc.2017.07.007. Epub 2017 Aug 31.
•   Woodman RJ, Mori TA, Burke V, Puddey IB, Watts GF, Beilin LJ
  Effects of purified eicosapentaenoic and docosahexaenoic acids on glycemic control, blood pressure, and serum lipids in type 2 diabetic patients with treated hypertension. Am J Clin Nutr. 2002 Nov;76(5):1007-15. doi: 10.1093/ajcn/76.5.1007.
•   Yagi S, Fukuda D, Aihara KI, Akaike M, Shimabukuro M, Sata M
  n-3 Polyunsaturated Fatty Acids: Promising Nutrients for Preventing Cardiovascular Disease. J Atheroscler Thromb. 2017 Oct 1;24(10):999-1010. doi: 10.5551/jat.RV17013. Epub 2017 Aug 24.
•   Yokoyama M, Origasa H, Matsuzaki M, Matsuzawa Y, Saito Y, Ishikawa Y, Oikawa S, Sasaki J, Hishida H, Itakura H, Kita T, Kitabatake A, Nakaya N, Sakata T, Shimada K, Shirato K; Japan EPA lipid intervention study (JELIS) Investigators
  Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet. 2007 Mar 31;369(9567):1090-8. doi: 10.1016/S0140-6736(07)60527-3. Erratum In: Lancet. 2007 Jul 21;370(9583):220.

Study of the Effect of Eicosapentaenoic Acid (EPA) on Markers of Atherothrombosis in Patients With Type-2 Diabetes

Details for clinical trial NCT06129526