Diabetic Artery Obstruction: is it Possible to Reduce Ischemic Events With Cilostazol?
NCT ID: NCT02983214
Last Updated: 2020-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
826 participants
INTERVENTIONAL
2016-11-30
2019-10-31
Brief Summary
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Detailed Description
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Recent pharmacodynamic studies have demonstrated that adding cilostazol to aspirin or clopidogrel may represent an effective way to overcome high on-treatment platelet reactivity. Additionally, clinical studies have shown that the addition of cilostazol to dual antiplatelet therapy with aspirin and clopidogrel (triple antiplatelet therapy, TAPT) in patients with acute coronary syndrome undergoing PCI offers significant clinical benefit. This favorable effect of cilostazol was confirmed in a recent meta-analysis which included nine studies and a total of 2,179 patients undergoing PCI. Furthermore, other clinical studies have shown that administration of TAPT with cilostazol reduces restenosis after PCI. Finally, the administration of dual antiplatelet therapy with cilostazol and aspirin significantly reduces the progression of symptomatic intracranial arterial stenosis compared to monotherapy with aspirin.
The aim of The Diabetic artery Obstruction: is it possible to Reduce Ischemic events with Cilostazol? (DORIC) trial is to investigate the clinical efficacy and safety of dual antiplatelet therapy (DAPT) with clopidogrel and cilostazol versus clopidogrel alone in preventing ischemic vascular eventsin patients with type 2 diabetes (DM2) and symptomatic peripheral arterial disease (PAD).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Clopidogrel
Clopidogrel 75 mg/day
Clopidogrel
Clopidogrel plus cilostazol
Clopidogrel 75 mg/day plus cilostazol 100 mg twice/day
Clopidogrel
Cilostazol
Interventions
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Clopidogrel
Cilostazol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with atrial fibrillation taking any anticoagulant therapy or patients with a history of cardioembolic ischemic stroke or hemorrhagic stroke.
* Patients with a history (≤ 12 months) of acute coronary syndrome receiving dual antiplatelet therapy, or patients receiving monotherapy with aspirin.
* Patients with hepatic impairment (child-Pugh staging, calibration ≥ 5) or renal impairment (creatinine clearance ≤ 30ml / min), recent peptic ulcer, a history of hypersensitivity to cilostazol, cancer patients undergoing treatment.
50 Years
ALL
No
Sponsors
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LIBYTEC Pharmaceutical S.A.
UNKNOWN
University of Ioannina
OTHER
Responsible Party
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Alexandros Tselepis
Professor of Biochemistry and Clinical Chemistry
Locations
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Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina
Ioannina, Epirus, Greece
Countries
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References
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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.
Dindyal S, Kyriakides C. A review of cilostazol, a phosphodiesterase inhibitor, and its role in preventing both coronary and peripheral arterial restenosis following endovascular therapy. Recent Pat Cardiovasc Drug Discov. 2009 Jan;4(1):6-14. doi: 10.2174/157489009787260025.
Jeong YH, Tantry US, Bliden KP, Gurbel PA. Cilostazol to overcome high on-treatment platelet reactivity in korean patients treated with clopidogrel and calcium-channel blocker. Circ J. 2011;75(11):2534-6. doi: 10.1253/circj.cj-11-1076. Epub 2011 Oct 5. No abstract available.
Rizzo M, Corrado E, Patti AM, Rini GB, Mikhailidis DP. Cilostazol and atherogenic dyslipidemia: a clinically relevant effect? Expert Opin Pharmacother. 2011 Mar;12(4):647-55. doi: 10.1517/14656566.2011.557359. Epub 2011 Feb 2.
Liu Y, Fong M, Cone J, Wang S, Yoshitake M, Kambayashi J. Inhibition of adenosine uptake and augmentation of ischemia-induced increase of interstitial adenosine by cilostazol, an agent to treat intermittent claudication. J Cardiovasc Pharmacol. 2000 Sep;36(3):351-60. doi: 10.1097/00005344-200009000-00011.
Tselepis AD. Cilostazol-based triple antiplatelet therapy in the era of generic clopidogrel and new potent antiplatelet agents. Curr Med Res Opin. 2014 Jan;30(1):51-4. doi: 10.1185/03007995.2013.850070. Epub 2013 Oct 18. No abstract available.
Chapman TM, Goa KL. Cilostazol: a review of its use in intermittent claudication. Am J Cardiovasc Drugs. 2003;3(2):117-38. doi: 10.2165/00129784-200303020-00006.
Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, Gornik HL, Halperin JL, Jaff MR, Moneta GL, Olin JW, Stanley JC, White CJ, White JV, Zierler RE; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral Artery Disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011 Nov 1;58(19):2020-45. doi: 10.1016/j.jacc.2011.08.023. Epub 2011 Oct 6. No abstract available.
Spiliopoulos S. Antiplatelet therapy in critical limb ischemia: update on clopidogrel and cilostazol. J Cardiovasc Surg (Torino). 2014 Oct;55(5):631-40. Epub 2014 May 28.
Chen Y, Zhang Y, Tang Y, Huang X, Xie Y. Long-term clinical efficacy and safety of adding cilostazol to dual antiplatelet therapy for patients undergoing PCI: a meta-analysis of randomized trials with adjusted indirect comparisons. Curr Med Res Opin. 2014 Jan;30(1):37-49. doi: 10.1185/03007995.2013.850067. Epub 2013 Oct 18.
Min PK, Jung JH, Ko YG, Choi D, Jang Y, Shim WH. Effect of cilostazol on in-stent neointimal hyperplasia after coronary artery stenting: a quantative coronary angiography and volumetric intravascular ultrasound study. Circ J. 2007 Nov;71(11):1685-90. doi: 10.1253/circj.71.1685.
Douglas JS Jr, Holmes DR Jr, Kereiakes DJ, Grines CL, Block E, Ghazzal ZM, Morris DC, Liberman H, Parker K, Jurkovitz C, Murrah N, Foster J, Hyde P, Mancini GB, Weintraub WS; Cilostazol for Restenosis Trial (CREST) Investigators. Coronary stent restenosis in patients treated with cilostazol. Circulation. 2005 Nov 1;112(18):2826-32. doi: 10.1161/CIRCULATIONAHA.104.530097. Epub 2005 Oct 24.
Kwon SU, Cho YJ, Koo JS, Bae HJ, Lee YS, Hong KS, Lee JH, Kim JS. Cilostazol prevents the progression of the symptomatic intracranial arterial stenosis: the multicenter double-blind placebo-controlled trial of cilostazol in symptomatic intracranial arterial stenosis. Stroke. 2005 Apr;36(4):782-6. doi: 10.1161/01.STR.0000157667.06542.b7. Epub 2005 Mar 3.
Panagiotakos DB, Georgousopoulou EN, Pitsavos C, Chrysohoou C, Metaxa V, Georgiopoulos GA, Kalogeropoulou K, Tousoulis D, Stefanadis C; ATTICA Study group. Ten-year (2002-2012) cardiovascular disease incidence and all-cause mortality, in urban Greek population: the ATTICA Study. Int J Cardiol. 2015 Feb 1;180:178-84. doi: 10.1016/j.ijcard.2014.11.206. Epub 2014 Nov 26.
Toyoda K, Uchiyama S, Hoshino H, Kimura K, Origasa H, Naritomi H, Minematsu K, Yamaguchi T; CSPS.com Study Investigators. Protocol for Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com): a randomized, open-label, parallel-group trial. Int J Stroke. 2015 Feb;10(2):253-8. doi: 10.1111/ijs.12420. Epub 2014 Dec 8.
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.
Other Identifiers
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Cilo-UoI-2016
Identifier Type: -
Identifier Source: org_study_id