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
About this trial
This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring cardiovascular disease, atherosclerosis
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
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
NCT ID
NCT02933788
First Posted
September 18, 2016
Last Updated
October 12, 2016
Sponsor
Kangbuk Samsung Hospital
Collaborators
Asan Medical Center
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
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Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients
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