Clopidogrel Versus Cilostazol on Vessels

Comparing Clopidogrel and Cilostazol in Type 2 Diabetes Patients With Carotid Atherosclerosis

Diabetes is an increasing cause of atherosclerotic and cardiovascular illnesses in South Korea. The clinical application of ultrasound for measuring carotid intima-media thickness, which helps in early detection and surveillance of atherosclerosis, is advancing. Due to lifestyle changes and an aging population, Koreans, especially diabetics, are developing more vascular diseases and are at higher risk for peripheral vascular disorders. Diabetics with lower limb peripheral artery disease require effective therapy to avoid major complications and a reduced quality of life. Although licensed for symptom control, Clopidogrel and Cilostazol have not yet been established for primary prevention of cardiovascular risks. These medications will be evaluated for their potential as primary preventive agents against cardiovascular disease in type 2 diabetes patients. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and to evaluate their influence on hemorheological changes in individuals with Type 2 diabetes. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and evaluating their influence on alterations in blood flow among individuals with Type 2 diabetes.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerosis; Type 2 Diabetes
• Intervention / Treatment: Drug: Clopidogrel; Drug: Cilostazol

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Minji Sohn, Ph.D.; Phone Number: +82317878443; Email: rainbowmjs@naver.com
• Study Contact Backup: Name: Soo Lim, MD. Ph.D.; Phone Number: +82317877035; Email: limsoo@snu.ac.kr

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Soo Lim; Phone Number: 82317877035 +82317877035; Email: limsoo@snu.ac.kr
      • Contact: Minji Sohn; Phone Number: 82317878443 +82317878443; Email: rainbowmjs@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults with diabetes aged 19 and older
• Individuals with a carotid ultrasound cIMT (carotid intima-media thickness) of 1.0mm or more
• Those who have not changed their combination therapy medications (including oral hypoglycemics, antihypertensives, and lipid-lowering drugs) in the last three months
• Individuals with an HbA1c level of 10% or less
• Those who have voluntarily signed the written consent form and agreed to participate in the study

Exclusion Criteria:

• Individuals currently using antithrombotic or anticoagulant medications other than aspirin

• Individuals with bleeding or conditions that may increase the risk of bleeding, such as:

  • Hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary bleeding, hemoptysis, vitreous hemorrhage, etc
  • Active peptic ulcer, hemorrhagic stroke within the last 6 months, surgical operations within the last 3 months, proliferative diabetic retinopathy, uncontrolled hypertension
• Patients who have had cerebrovascular or cardiovascular complications within the past 6 months (including stroke, transient ischemic attacks, myocardial infarction, unstable angina, coronary artery bypass graft, or percutaneous coronary intervention)
• Patients with severe renal or hepatic diseases
• Patients with congestive heart failure
• Individuals with a history of hypersensitivity to the drug or its components
• Pregnant women or women who may be pregnant
• Women who are breastfeeding or plan to breastfeed during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clopidogrel; Clopidogrel 75mg once daily	Drug: Clopidogrel; Clopidogrel 75mg once daily; Other Names: Platless Tab.
Active Comparator: Cilostazol; Cilostazol 200mg per day	Drug: Cilostazol; Cilostazol 200mg per day; Other Names: Cilostan CR Tab. 200mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of carotid intima-media thickness	mm	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of circulation	measured by ankle brachial index and laser doppler	52 weeks
Changes of glucose	mg/dL	26 and 52 weeks
Changes of body weight	kg	26 and 52 weeks
Changes of whole body fat	measured by bioelectrical impedance analysis	26 and 52 weeks
Changes of blood pressures	systolic, diastolic (mmHg)	26 and 52 weeks
Changes of lipids	total cholesterol, triglycerides, LDLc, HDLc (mg/dL)	26 and 52 weeks
Changes of peripheral pain or ischemic symptoms	measured by questionnaires (visual analogue scale: 100)	26 and 52 weeks
Changes of laboratory values related to blood clot	prothrombin time, activated partial thromboplastin time	26 and 52 weeks
Changes of HbA1c	%	26 and 52 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Samjin Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Soo Lim, MD. Ph.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Arteriosclerosis; Arterial Occlusive Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Atherosclerosis; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Quinolines; Thiophenes; Tetrazoles; Ticlopidine; Thienopyridines; Clopidogrel; Cilostazol
• Other Study ID Numbers: B-2401-877-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No