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Clinical Trial Details

Trial ID: L6277
Source ID: NCT02933788
Associated Drug: Cilostazol
Title: Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Cilostazol|DRUG: Acetylsalicylic acid
Outcome Measures: Primary: platelet reactivity testing, Blood sampling is collected at baseline and after taking each drugs 14 days, in the fasting state . The rate of Aspirin reaction units(ARU) change compared baseline is measured through Verify Now. The rate of platelet aggregation(seconds) dut to collagen, epinephrine was compared through the platelet function testing-100. 1. Verify Now(ARU): It is a test developed to monitor the platelet aggregation inhibitory effects of anti-platelet drugs which used to prevent thrombosis and relapse it. By measuring the light transmission change, it outputs result to the aspirin response units(ARU) 2. Platelet function testing-100: platelet function analyser The cartridge membrane is coated by collagen as initial matrix for platelet adhesion. When platelet adhere to the collagen, it takes place the first physical stimulation. Then, another membrane component, Adenosine diphosphate induces platelet aggregation. The analysis equipment is measuring CT(closing time) in seconds., Change from Baseline 'platelet reactivity testing(Aspirin reaction units and platelet function testing-100) at 14 days | Secondary: Observation of Clinical laboratory data(total cholesterol, HDL, LDL and triglyceride, The rate of lipid profile(total cholesterol, HDL, LDL and triglyceride) change which is cardiovascular risk factors and diabetes mellitus complication indicators change are measured at baseline and after taking each drugs for 14 days. Thus, the effect of each drugs preventing complication in patients with diabetes mellitus may be analyzed. - total cholesterol(mg/dL)/ HDL(mg/dL)/ LDL(mg/dL)/ triglyceride(mg/dL)/ hsCRP(mg/dL)/ cluster of designation antigen 40(mg/dL)/ Dipeptidyl peptidase-4 enzyme activity(uM/ml)/ total and active glucagon like peptide-1(pmol/l), Change from baseline "total cholesterol, HDL, LDL and triglyceride, hsCRP, cluster of designation antigen 40, ligand, Dipeptidyl peptidase-4 enzyme activity, total and active glucagon like peptide-1' at 14 days.
Sponsor/Collaborators: Sponsor: Kangbuk Samsung Hospital | Collaborators: Asan Medical Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 116
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2016-10
Completion Date: 2018-12
Results First Posted:
Last Update Posted: 2016-10-14
Locations:
URL: https://clinicaltrials.gov/show/NCT02933788