Clinical trial NCT02933788: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: cardiovascular disease
atherosclerosis
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
First posted: 2016-10-14
Enrollment: 116
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: platelet reactivity testing
timeFrame: Change from Baseline 'platelet reactivity testing(Aspirin reaction units and platelet function testing-100) at 14 days
Secondary outcomes:
measure: Observation of Clinical laboratory data(total cholesterol, HDL, LDL and triglyceride
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Kanbuk Samsung Diabetes Center
name: Cheol Young Park, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kim JD, Park CY, Ahn KJ, Cho JH, Choi KM, Kang JG, Kim JH, Lee KY, Lee BW, Mok JO, Moon MK, Park JY, Park SW. Non-HDL cholesterol is an independent risk factor for aspirin resistance in obese patients with type 2 diabetes. Atherosclerosis. 2014 May;234(1):146-51. doi: 10.1016/j.atherosclerosis.2014.01.015. Epub 2014 Feb 12.
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citation: Hong S, Lee WJ, Park CY. Comparative Study of Ex Vivo Antiplatelet Activity of Aspirin and Cilostazol in Patients with Diabetes and High Risk of Cardiovascular Disease. Endocrinol Metab (Seoul). 2022 Apr;37(2):233-242. doi: 10.3803/EnM.2021.1353. Epub 2022 Apr 6.