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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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Cilostazol Drug: Acetylsalicylic acid Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of aSpirin Versus CilOstazol for Inhibition of Antiplatelet aggRegaTion in Type 2 DM Patients
Study Start Date : October 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cilostazol group
Cilostazol Cilostazol 200mg tablet by mouth, once daily for 14 days
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

Active Comparator: Aspirin group
Acetylsalicylic acid Acetylsalicylic acid 100mg tablet by mouth, once daily for 14 days
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)




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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933788


Contacts
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Contact: Ji Hyun Kim, Fellow +2-2001-8503 kjhys0527@hanmail.net
Contact: Cheol Young Park, Professor +2-2001-1550 cydoctor@chol.com

Sponsors and Collaborators
Kangbuk Samsung Hospital
Asan Medical Center
Investigators
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Principal Investigator: Cheol Young Park, Professor Kanbuk Samsung Diabetes Center

Additional Information:
Publications:
Global status report on noncommunicable diseases 2010

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Responsible Party: Ji Hyun Kim, Fellowship, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT02933788     History of Changes
Other Study ID Numbers: ESCORT_DM
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ji Hyun Kim, Kangbuk Samsung Hospital:
cardiovascular disease
atherosclerosis
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aspirin
Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors