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Diabetic Artery Obstruction: is it Possible to Reduce Ischemic Events With Cilostazol? (DORIC)

This study is currently recruiting participants.
Verified December 2016 by Alexandros Tselepis, University of Ioannina
Sponsor:
ClinicalTrials.gov Identifier:
NCT02983214
First Posted: December 6, 2016
Last Update Posted: December 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alexandros Tselepis, University of Ioannina
  Purpose
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.

Condition Intervention Phase
Ischemic Stroke Peripheral Artery Disease Diabetes Mellitus, Type 2 Drug: Clopidogrel Drug: Cilostazol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Study of the Efficacy and Safety of Cilostazol in the Prevention of Ischemic Vascular Events in Diabetic Patients With Symptomatic Peripheral Artery Disease.

Resource links provided by NLM:


Further study details as provided by Alexandros Tselepis, University of Ioannina:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 months ]
    Death from vascular causes: cardiovascular or cerebrovascular

  • Number of participants who suffer from bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria during the entire follow-up period. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Number of participants whose major secondary efficacy end point which is the free walking distance or the ankle brachial index (ABI) value will be improved during the entire follow-up period. [ Time Frame: 12 months ]
  • Number of participants who suffer from the secondary safety end points which are palpitations, tachycardia, tachyarrhythmia, hypotension, headache, nausea, diarrhea, blood disorders, drug interruption. [ Time Frame: 12 months ]
    Blood disorders: thrombocytopenia, leukopenia, agranulocytosis, pancytopenia, aplastic anemia


Estimated Enrollment: 1885
Study Start Date: November 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clopidogrel
Clopidogrel 75 mg/day
Drug: Clopidogrel
Other Name: Plavix, Clodelib, Clovelen
Active Comparator: Clopidogrel plus cilostazol
Clopidogrel 75 mg/day plus cilostazol 100 mg twice/day
Drug: Clopidogrel
Other Name: Plavix, Clodelib, Clovelen
Drug: Cilostazol
Other Name: Claudiasil

Detailed Description:

Cilostazol is a quinoline derivative that selectively and reversibly inhibits cellular cyclic adenosine monophosphate (cAMP) phosphodiesterase III, thus suppressing cAMP degradation and maintaining its high intracellular levels. Through this mechanism, cilostazol inhibits platelet aggregation, exerting significant antiplatelet and antithrombotic activity. Cilostazol also improves endothelial function and exerts anti-inflammatory, anti-atherogenic and vasodilatory effects. Additionally, cilostazol inhibits equilibrative nucleoside transporter-1 (ENT-1) which is responsible for the cellular uptake of adenosine, reducing its plasma concentration. Through this mechanism, cilostazol maintains high extracellular adenosine concentration allowing adenosine to exert its biological effects. Thus, cilostazol not only shows potent antithrombotic activity, but also prevents restenosis after percutaneous coronary intervention (PCI). Finally, cilostazol has beneficial effects in the lipidemic profile reducing triglyceride levels and increasing HDL-cholesterol. Clinical studies have shown that in patients with intermittent claudication, cilostazol increases the walking distance. Based on these studies, cilostazol administration in combination with an antiplatelet drug (clopidogrel or aspirin) is recommended for patients with intertermittent claudication.

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).

  Eligibility

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ΑΒΙ.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983214


Locations
Greece
Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina Recruiting
Ioannina, Epirus, Greece, 45110
Contact: Alexandros D Tselepis, Professor    +302651008365    atselep@uoi.gr   
Sponsors and Collaborators
University of Ioannina
  More Information

Publications:

Responsible Party: Alexandros Tselepis, Professor of Biochemistry and Clinical Chemistry, University of Ioannina
ClinicalTrials.gov Identifier: NCT02983214     History of Changes
Other Study ID Numbers: Cilo-UoI-2016
First Submitted: November 29, 2016
First Posted: December 6, 2016
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alexandros Tselepis, University of Ioannina:
Cilostazol
Clopidogrel
Peripheral Artery Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Ischemia
Diabetes Mellitus, Type 2
Peripheral Arterial Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Clopidogrel
Cilostazol
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors