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Trial record 26 of 1302 for:    ASPIRIN AND Platelet Aggregation

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

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ClinicalTrials.gov Identifier: NCT02933788
Recruitment Status : Unknown
Verified October 2016 by Ji Hyun Kim, Kangbuk Samsung Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 14, 2016
Last Update Posted : October 14, 2016
Sponsor:
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
Ji Hyun Kim, Kangbuk Samsung Hospital

Tracking Information
First Submitted Date  ICMJE September 18, 2016
First Posted Date  ICMJE October 14, 2016
Last Update Posted Date October 14, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
platelet reactivity testing [ Time Frame: Change from Baseline 'platelet reactivity testing(Aspirin reaction units and platelet function testing-100) at 14 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
Observation of Clinical laboratory data(total cholesterol, HDL, LDL and triglyceride [ 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. ]
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients
Official Title  ICMJE Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Cilostazol
    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.
    Other Name: Pletal
  • Drug: Acetylsalicylic acid
    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.
    Other Name: Aspirin
Study Arms  ICMJE
  • Experimental: Cilostazol group
    Cilostazol Cilostazol 200mg tablet by mouth, once daily for 14 days
    Intervention: Drug: Cilostazol
  • Active Comparator: Aspirin group
    Acetylsalicylic acid Acetylsalicylic acid 100mg tablet by mouth, once daily for 14 days
    Intervention: Drug: Acetylsalicylic acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 12, 2016)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02933788
Other Study ID Numbers  ICMJE ESCORT_DM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ji Hyun Kim, Kangbuk Samsung Hospital
Study Sponsor  ICMJE Kangbuk Samsung Hospital
Collaborators  ICMJE Asan Medical Center
Investigators  ICMJE
Principal Investigator: Cheol Young Park, Professor Kanbuk Samsung Diabetes Center
PRS Account Kangbuk Samsung Hospital
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP