Cilostazol and Aspirin for Cardiovascular Event Prevention in Patients With Type 2 Diabetes
Recruiting
Phase 4Interventional Study
Type 2 Diabetes Mellitus (T2DM)Atherosclerosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
1,200 (estimated)
Sponsor
Seoul National University Bundang Hospital · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* 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 wav…
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
* 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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.