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Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cilostazol
Acetylsalicylic acid
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring cardiovascular disease, atherosclerosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Who have one more following risk factor:

    • Family history of cardiovascular disease
    • Hypertension
    • Smoking History
    • Dyslipidemia
    • Albuminuria
  • Who do not have high risk of bleeding
  • Who stop taking Cilostazol or Aspirin before randomized period 1months or
  • Who have never taken the drugs

Exclusion Criteria:

  • Type 1 diabetes mellitus, gestational diabetes
  • Who with history of macrovascular complication including cardiovascular disease, cerebrovascular disease and peripheral vascular disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cilostazol group

    Aspirin group

    Arm Description

    Cilostazol Cilostazol 200mg tablet by mouth, once daily for 14 days

    Acetylsalicylic acid Acetylsalicylic acid 100mg tablet by mouth, once daily for 14 days

    Outcomes

    Primary Outcome Measures

    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. 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) 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.

    Secondary Outcome Measures

    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)

    Full Information

    First Posted
    September 18, 2016
    Last Updated
    October 12, 2016
    Sponsor
    Kangbuk Samsung Hospital
    Collaborators
    Asan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02933788
    Brief Title
    Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients
    Official Title
    Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kangbuk Samsung Hospital
    Collaborators
    Asan Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the more suitable treatment for the prevention of vascular complications in diabetes patents who were at high cardiovascular risk group by comparing the platelet aggregation inhibitory effect of aspirin and cilostazol.
    Detailed Description
    Diabetes is a dangerous disease with high risk of vascular complications. Thus, to prevent these vascular complication, antithrombotic drug may be administered. Representative antithrombotic agents are aspirin and cilostazol. However, recent studies suggested that aspirin did not have sufficient effect to prevent vascular complications of diabetes. For that reason, it have been reported that antithrombotic effects of aspirin were falling in diabetes patients, so-called 'aspirin resistance. On the other hand, cilostazol used as the control drug inhibits atherosclerosis in diabetes patients in the studies of Asia including Korea, and it is effective to inhibit the risk of various cardiovascular disease. Therefore, cilostazol is likely to use drugs as substitute for aspirin therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    cardiovascular disease, atherosclerosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    116 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cilostazol group
    Arm Type
    Experimental
    Arm Description
    Cilostazol Cilostazol 200mg tablet by mouth, once daily for 14 days
    Arm Title
    Aspirin group
    Arm Type
    Active Comparator
    Arm Description
    Acetylsalicylic acid Acetylsalicylic acid 100mg tablet by mouth, once daily for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Cilostazol
    Other Intervention Name(s)
    Pletal
    Intervention Description
    Cilostazol sustained release capsule is new drugs developed by Otsuka Korea. This drugs have platelet aggregation inhibiting action, peripheral vasodilating action and endothelial function improving action.
    Intervention Type
    Drug
    Intervention Name(s)
    Acetylsalicylic acid
    Other Intervention Name(s)
    Aspirin
    Intervention Description
    Aspirin may prevent coronary thrombosis in patients with cardiovascular event risk factors, such as ischemic heart disease family history, hypertension, diabetes mellitus, dyslipidemia and obesity.
    Primary Outcome Measure Information:
    Title
    platelet reactivity testing
    Description
    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. 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) 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.
    Time Frame
    Change from Baseline 'platelet reactivity testing(Aspirin reaction units and platelet function testing-100) at 14 days
    Secondary Outcome Measure Information:
    Title
    Observation of Clinical laboratory data(total cholesterol, HDL, LDL and triglyceride
    Description
    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)
    Time Frame
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Who have one more following risk factor: Family history of cardiovascular disease Hypertension Smoking History Dyslipidemia Albuminuria Who do not have high risk of bleeding Who stop taking Cilostazol or Aspirin before randomized period 1months or Who have never taken the drugs Exclusion Criteria: Type 1 diabetes mellitus, gestational diabetes Who with history of macrovascular complication including cardiovascular disease, cerebrovascular disease and peripheral vascular disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ji Hyun Kim, Fellow
    Phone
    +2-2001-8503
    Email
    kjhys0527@hanmail.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cheol Young Park, Professor
    Phone
    +2-2001-1550
    Email
    cydoctor@chol.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cheol Young Park, Professor
    Organizational Affiliation
    Kanbuk Samsung Diabetes Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    Global status report on noncommunicable diseases 2010
    Results Reference
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    American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes. 2015 Apr;33(2):97-111. doi: 10.2337/diaclin.33.2.97. No abstract available.
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    Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients

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