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RecruitingNCT06402747Updated May 5, 2026

Clopidogrel Versus Cilostazol on Vessels

A Phase 4 interventional study of Clopidogrel and Cilostazol in Type 2 Diabetes and Atherosclerosis, sponsored by Seoul National University Bundang Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Seoul National University Bundang Hospital · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes
  • Atherosclerosis
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 120 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Clopidogrel

    Clopidogrel 75mg once daily

    Drug: Clopidogrel

  • Active comparator
    Cilostazol

    Cilostazol 200mg per day

    Drug: Cilostazol

Interventions

  • DrugClopidogrel

    Clopidogrel 75mg once daily

    Also known as: Platless Tab.

  • DrugCilostazol

    Cilostazol 200mg per day

    Also known as: Cilostan CR Tab. 200mg

06

What researchers measure

Primary outcomes

  1. Changes of carotid intima-media thickness

    mm

    Time frame: 52 weeks

Secondary outcomes

  1. Changes of circulation

    measured by ankle brachial index and laser doppler

    Time frame: 52 weeks

  2. Changes of HbA1c

    %

    Time frame: 26 and 52 weeks

  3. Changes of glucose

    mg/dL

    Time frame: 26 and 52 weeks

  4. Changes of body weight

    kg

    Time frame: 26 and 52 weeks

  5. Changes of whole body fat

    measured by bioelectrical impedance analysis

    Time frame: 26 and 52 weeks

  6. Changes of blood pressures

    systolic, diastolic (mmHg)

    Time frame: 26 and 52 weeks

  7. Changes of lipids

    total cholesterol, triglycerides, LDLc, HDLc (mg/dL)

    Time frame: 26 and 52 weeks

  8. Changes of peripheral pain or ischemic symptoms

    measured by questionnaires (visual analogue scale: 100)

    Time frame: 26 and 52 weeks

  9. Changes of laboratory values related to blood clot

    prothrombin time, activated partial thromboplastin time

    Time frame: 26 and 52 weeks

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 13620, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06402747
Lead sponsor
Seoul National University Bundang Hospital
Collaborators
Samjin Pharmaceutical Co., Ltd.
Responsible party
Soo Lim (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
May 7, 2024
Start date
Apr 16, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
May 5, 2026

Study contacts

Soo Lim, MD. Ph.D.
Contact
limsoo@snu.ac.kr
+82317877035
Minji Sohn, Ph.D.
Contact
rainbowmjs@naver.com
+82317878443
Soo Lim, MD. Ph.D.
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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