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Clinical Trial Details

Trial ID: L4839
Source ID: NCT02983214
Associated Drug: Clopidogrel
Title: Diabetic Artery Obstruction: is it Possible to Reduce Ischemic Events With Cilostazol?
Acronym: DORIC
Status: COMPLETED
Study Results: NO
Results:
Conditions: Ischemic Stroke|Peripheral Artery Disease|Diabetes Mellitus, Type 2
Interventions: DRUG: Clopidogrel|DRUG: Cilostazol
Outcome Measures: 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|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|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
Sponsor/Collaborators: Sponsor: University of Ioannina | Collaborators: LIBYTEC Pharmaceutical S.A.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 826
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2016-11
Completion Date: 2019-10
Results First Posted:
Last Update Posted: 2020-12-29
Locations: Atherothrombosis Research Centre / Laboratory of Biochemistry, University of Ioannina, Ioannina, Epirus, 45110, Greece
URL: https://clinicaltrials.gov/show/NCT02983214