Type 2 DiabetesPhase 4NCT06402747
Clopidogrel Versus Cilostazol on Vessels
A Phase 4 study testing Clopidogrel and Cilostazol in people with Type 2 Diabetes and Atherosclerosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes, Atherosclerosis
- What is being tested?
- Clopidogrel and Cilostazol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Apr 2024to 31 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Soo Lim, +82317877035 ext. 82317877035, limsoo@snu.ac.kr
Minji Sohn, +82317878443 ext. 82317878443, rainbowmjs@naver.com
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes, Atherosclerosis
- Being tested
- Clopidogrel, Cilostazol
- Medical subject headings
- Diabetes Mellitus, Type 2, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Platless Tab.
Clopidogrel 75mg once daily
CilostazolDrug
Also called Cilostan CR Tab. 200mg
Cilostazol 200mg per day
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Experimental | Clopidogrel 75mg once daily Receives: Drug: Clopidogrel |
| Cilostazol | Active comparator | Cilostazol 200mg per day Receives: Drug: Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of carotid intima-media thickness
mm
Measured: 52 weeks
Secondary outcomes (9)
Changes of circulation
measured by ankle brachial index and laser doppler
Measured: 52 weeks
Changes of HbA1c
%
Measured: 26 and 52 weeks
Changes of glucose
mg/dL
Measured: 26 and 52 weeks
Changes of body weight
kg
Measured: 26 and 52 weeks
Changes of whole body fat
measured by bioelectrical impedance analysis
Measured: 26 and 52 weeks
Changes of blood pressures
systolic, diastolic (mmHg)
Measured: 26 and 52 weeks
Changes of lipids
total cholesterol, triglycerides, LDLc, HDLc (mg/dL)
Measured: 26 and 52 weeks
Changes of peripheral pain or ischemic symptoms
measured by questionnaires (visual analogue scale: 100)
Measured: 26 and 52 weeks
Changes of laboratory values related to blood clot
prothrombin time, activated partial thromboplastin time
Measured: 26 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start16 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, MD. Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402747
- Sponsor's protocol ID
- B-2401-877-002
- Status last verified
- May 2026
- First submitted
- 26 Apr 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Clopidogrel and Cilostazol in Type 2 Diabetes Patients With Carotid Atherosclerosis
- ClinicalTrials.gov ID
- NCT06402747
- Acronym / sponsor ID
- B-2401-877-002
- Conditions
- Type 2 Diabetes, Atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd.
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Experimental | Drug: ClopidogrelClopidogrel 75mg once daily |
| Cilostazol | Active comparator | Drug: CilostazolCilostazol 200mg per day |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Individuals currently using antithrombotic or anticoagulant medications other than aspirin
- Individuals with bleeding or conditions that may increase the risk of bleeding, such as:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelAlso: Platless Tab.Clopidogrel 75mg once daily | Drug | Clopidogrel |
| CilostazolAlso: Cilostan CR Tab. 200mgCilostazol 200mg per day | Drug | Cilostazol |
Primary outcome
Changes of carotid intima-media thickness
Time frame: 52 weeks
mm
9 secondary outcomes
Changes of circulation
Time frame: 52 weeks
Changes of HbA1c
Time frame: 26 and 52 weeks
Changes of glucose
Time frame: 26 and 52 weeks
Changes of body weight
Time frame: 26 and 52 weeks
Changes of whole body fat
Time frame: 26 and 52 weeks
Changes of blood pressures
Time frame: 26 and 52 weeks
Changes of lipids
Time frame: 26 and 52 weeks
Changes of peripheral pain or ischemic symptoms
Time frame: 26 and 52 weeks
Changes of laboratory values related to blood clot
Time frame: 26 and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soo Lim, MD. Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel and Cilostazol in people with Type 2 Diabetes and Atherosclerosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soo Lim, MD. Ph.D. (+82317877035, limsoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of carotid intima-media thickness (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.