Type 2 Diabetes Mellitus (T2DM)Phase 4Cilo-AsaNCT07719894
Cilostazol and Aspirin for Cardiovascular Event Prevention in Patients With Type 2 Diabetes
A Phase 4 study testing Cilostazol and Aspirin in people with Type 2 Diabetes Mellitus (T2DM) and Atherosclerosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Patients with type 2 diabetes and cardiovascular risk factors are at increased risk of cardiovascular events. Therefore, a multi-center prospective randomized study will be conducted to compare the efficacy and safety of cilostazol and aspirin for the prevention of major adverse cardiac and cerebrovascular events… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Atherosclerosis
- What is being tested?
- Cilostazol and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 May 2026to 31 Dec 2028
- 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
- Individuals with type 2 diabetes mellitus were eligible if they were aged ≥19 years
- Individuals with subclinical atherosclerosis or metabolic syndrome, defined as at least one of the following:
- Carotid intima-media thickness ≥ 1 mm
- Ankle-brachial index < 0.9 - Pulse wave velocity ≥ 9 m/s
- Flow-mediated vasodilatation < 5%
- Coronary artery calcium score ≥ 40
Show all 11Show fewer
- Coronary artery stenosis ≥ 20% or ≤ 70%
- Peripheral artery occlusive disease ≥ 20%
- Metabolic syndrome
- Individuals with HbA1c ≤ 9.9%
- Individuals who voluntarily agree to participate in the study and provide written informed consent
Who cannot join
- Patients with a history of major cardiovascular events, including myocardial infarction, stroke, or heart failure
- Patients with heart failure (NYHA I~IV)
- Patients with current active bleeding or suspected bleeding
- Patients with suspected bleeding tendency or hematologic disorder, such as hemophilia or thrombocytopenia
- Patients recently diagnosed with gastrointestinal ulcerative disease
- Patients with inadequately controlled hypertension, defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg
Show all 17Show fewer
- Patients with severe renal dysfunction, defined as estimated glomerular filtration rate < 30 mL/min/1.73 m²
- Patients with liver enzyme levels greater than 3 times the upper limit of normal or chronic liver disease
- Individuals currently taking antiplatelet or antithrombotic agents
- Individuals who are pregnant or breastfeeding
- Patients with a history of hypersensitivity to any component of the study drugs
- Patients with complications of coronary artery stenosis
- Patients with QT prolongation
- Patients with a sigmoid-shaped ventricular septum or risk of sigmoid-shaped ventricular septum
- Individuals with alcohol addiction
- Patients with asthma
- Patients deemed unsuitable for participation in the study based on the investigator's judgment
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
Jiyoon Lee, 82-10-4850-4828
About this study
Official title: Comparison of Efficacy and Safety Between Aspirin and Cilostazol on Cardiovascular Event in Patients at High Risk of Cardiovascular Disease, Randomization.
Patients with type 2 diabetes and cardiovascular risk factors are at increased risk of cardiovascular events. Therefore, a multi-center prospective randomized study will be conducted to compare the efficacy and safety of cilostazol and aspirin for the prevention of major adverse cardiac and cerebrovascular events (MACCE) in high-risk patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Atherosclerosis
- Being tested
- Cilostazol, Aspirin
- Keywords
- Major Adverse Cardiac and Cerebrovascular Events, Cilostazol, Aspirin
- 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.
CilostazolDrug
Drug: Cilostazol Other Name: Pletaal SR Capsule
AspirinDrug
Drug: AspirinOther Name: ASA
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Experimental | Not described Receives: Drug: Cilostazol |
| Aspirin | Active comparator | Not described Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Incidence of major adverse cardiac and cerebrovascular events (MACCE), defined as myocardial infarction, stroke, cardiac or peripheral revascularization, hospitalization for symptomatic vascular ischemia, amputation, hospitalization for heart failure, or cardiovascular disease-related death
Measured: Up to 156 weeks
Secondary outcomes (20)
Incidence of Three-Point Major Adverse Cardiovascular Events
Incidence of three-point major adverse cardiovascular events, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death
Measured: Up to 156 weeks
Incidence of Heart Failure Events
Incidence of heart failure events during the study period
Measured: Up to 156 weeks
Incidence of Peripheral Vascular Events
Incidence of peripheral vascular events, including limb ischemia, amputation, and revascularization.
Measured: Up to 156 weeks
Change in CK-MB Level
Change from baseline in serum creatine kinase-MB level.
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Troponin-I Level
Change from baseline in serum troponin-I level
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Fasting Glucose Level
Change from baseline in fasting glucose level
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in HbA1c Level
Change from baseline in HbA1c level
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Insulin Level
Change from baseline in insulin level
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Total Cholesterol Level
Change from baseline in serum total cholesterol level
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Triglyceride(TG) Level
Change from baseline in serum TG level
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in HDL Cholesterol Level
Change from baseline in serum high-density lipoprotein (HDL) cholesterol level
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in LDL Cholesterol Level
Change from baseline in serum LDL(low-density lipoprotein) cholesterol level
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in hsCRP Level
Change from baseline in high-sensitivity C-reactive protein level
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Body Composition
Change in body composition measured by BIA
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in the Number of Metabolic Syndrome Components
Change in the number of metabolic syndrome components.
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Framingham Risk Score
Change in Framingham Risk Score. Higher scores indicate a higher estimated risk of cardiovascular disease.
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in PREVENT Risk Score
Change in Predicting Risk of Cardiovascular Disease EVENTs (PREVENT) risk score. Higher scores indicate a higher estimated risk of cardiovascular disease.
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in SCORE2
Change in in Systematic COronary Risk Evaluation 2 (SCORE2). Higher scores indicate a higher estimated risk of cardiovascular disease.
Measured: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in coronary artery calcium score
Change in coronary artery calcium score (CACS) measured by coronary computed tomography angiography The coronary artery calcium score is measured using the Agatston method; the minimum value is 0, there is no fixed maximum value, and higher scores indicate greater coronary artery calcification.
Measured: Baseline and 156 weeks
Change in Coronary Artery Stenosis
Change in coronary artery stenosis measured by coronary computed tomography angiography
Measured: Baseline and 156 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start6 May 2026
- Primary completionDec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719894
- Sponsor's protocol ID
- B-2509-995-002
- Other IDs
- B-2509-995-002
- Acronym
- Cilo-Asa
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share de-identified individual participant data has not yet been determined. Any future sharing will require approval from the Institutional Review Board of the coordinating institution and appropriate data sharing agreements with participating institutions.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety Between Aspirin and Cilostazol on Cardiovascular Event in Patients at High Risk of Cardiovascular Disease, Randomization.
- ClinicalTrials.gov ID
- NCT07719894
- Acronym / sponsor ID
- Cilo-Asa / B-2509-995-002
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Atherosclerosis
- Keywords
- Major Adverse Cardiac and Cerebrovascular Events, Cilostazol, Aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jul 2026 (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.
Patients with type 2 diabetes and cardiovascular risk factors are at increased risk of cardiovascular events. Therefore, a multi-center prospective randomized study will be conducted to compare the efficacy and safety of cilostazol and aspirin for the prevention of major adverse cardiac and cerebrovascular events (MACCE) in high-risk patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | Experimental | Drug: Cilostazol |
| Aspirin | Active comparator | Drug: Aspirin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals with type 2 diabetes mellitus were eligible if they were aged ≥19 years
- Individuals with subclinical atherosclerosis or metabolic syndrome, defined as at least one of the following:
- Carotid intima-media thickness ≥ 1 mm
- Ankle-brachial index < 0.9 - Pulse wave velocity ≥ 9 m/s
- Flow-mediated vasodilatation < 5%
Key exclusion criteria (17 listed)
- Patients with a history of major cardiovascular events, including myocardial infarction, stroke, or heart failure
- Patients with heart failure (NYHA I~IV)
- Patients with current active bleeding or suspected bleeding
- Patients with suspected bleeding tendency or hematologic disorder, such as hemophilia or thrombocytopenia
- Patients recently diagnosed with gastrointestinal ulcerative disease
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 |
|---|---|---|
| CilostazolDrug: Cilostazol Other Name: Pletaal SR Capsule | Drug | Cilostazol |
| AspirinDrug: AspirinOther Name: ASA | Drug | Aspirin |
Primary outcome
Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: Up to 156 weeks
Incidence of major adverse cardiac and cerebrovascular events (MACCE), defined as myocardial infarction, stroke, cardiac or peripheral revascularization, hospitalization for symptomatic vascular ischemia, amputation, hospitalization for heart failure, or cardiovascular disease-related death
20 secondary outcomes
Incidence of Three-Point Major Adverse Cardiovascular Events
Time frame: Up to 156 weeks
Incidence of Heart Failure Events
Time frame: Up to 156 weeks
Incidence of Peripheral Vascular Events
Time frame: Up to 156 weeks
Change in CK-MB Level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Troponin-I Level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Fasting Glucose Level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in HbA1c Level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Insulin Level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Total Cholesterol Level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Triglyceride(TG) Level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in HDL Cholesterol Level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in LDL Cholesterol Level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in hsCRP Level
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Body Composition
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in the Number of Metabolic Syndrome Components
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in Framingham Risk Score
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in PREVENT Risk Score
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in SCORE2
Time frame: Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks
Change in coronary artery calcium score
Time frame: Baseline and 156 weeks
Change in Coronary Artery Stenosis
Time frame: Baseline and 156 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 22 Jul 2026.
- Individual participant dataSharing planned: Undecided. The plan to share de-identified individual participant data has not yet been determined. Any future sharing will require approval from the Institutional Review Board of the coordinating institution and appropriate data sharing agreements with participating institutions.
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
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.
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 Cilostazol and Aspirin in people with Type 2 Diabetes Mellitus (T2DM) 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 11 inclusion and 17 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 22 Jul 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 (82-10-9766-2706, limsoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) (time frame: Up to 156 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 22 Jul 2026.