Diabetes Mellitus, Type 2 Clinical Trial
— DORICOfficial title:
Study of the Efficacy and Safety of Cilostazol in the Prevention of Ischemic Vascular Events in Diabetic Patients With Symptomatic Peripheral Artery Disease.
Verified date | December 2020 |
Source | University of Ioannina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigation of the clinical efficacy and safety of dual antiplatelet therapy with clopidogrel and cilostazol versus clopidogrel alone in preventing ischemic vascular events in patients with type 2 diabetes and symptomatic peripheral arterial disease.
Status | Completed |
Enrollment | 826 |
Est. completion date | October 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Patients aged =50 years with DM2 and symptomatic PAD diagnosed clinically (according to Fontaine criteria, stage IIa or IIb and III) and by measuring the ???. Exclusion Criteria: - Congestive heart failure, history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular extrasystoles or QTc prolongation. - 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. |
Country | Name | City | State |
---|---|---|---|
Greece | Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina | Ioannina | Epirus |
Lead Sponsor | Collaborator |
---|---|
University of Ioannina | LIBYTEC Pharmaceutical S.A. |
Greece,
Chapman TM, Goa KL. Cilostazol: a review of its use in intermittent claudication. Am J Cardiovasc Drugs. 2003;3(2):117-38. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Epub 2005 Oct 24. — View Citation
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. Epub 2011 Oct 5. — View Citation
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. Review. — View Citation
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. Epub 2005 Mar 3. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who suffer from the primary efficacy end point which is composite of acute ischemic stroke/transient ischemic attack (TIA), myocardial infarction (MI), or death from vascular causes during the entire follow-up period. | Death from vascular causes: cardiovascular or cerebrovascular | 12 months | |
Primary | Number of participants who suffer from bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria during the entire follow-up period. | 12 months | ||
Secondary | Number of participants whose major secondary efficacy end point desribed in the description section is observed. | Acute ischemic stroke / TIA, AMI, coronary stent thrombosis, PCI, coronary restenosis, death from cardiovascular causes, death from any cause, hospitalization for acute limb ischemia, lower extremity arterial revascularization, improvement of ABI and pain-free walking distance values. | 12 months | |
Secondary | Number of participants who suffer from the secondary safety end points which are palpitations, tachycardia, headache, diarrhea, urticaria, neoplasms, blood disorders, drug interruption. | Blood disorders: transient thrombocytopenia, leukopenia | 12 months |
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