Cilostazol and Aspirin for Cardiovascular Event Prevention in Patients With Type 2 Diabetes

NCT07719894 | Recruiting Phase 4

• 1 other identifier: B-2509-995-002
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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 (MACCE) in high-risk patients with type 2 diabetes.

Conditions

Type 2 Diabetes Mellitus (T2DM); Atherosclerosis

Keywords

Major Adverse Cardiac and Cerebrovascular Events; Cilostazol; Aspirin

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 156 weeks

Secondary Outcomes (20)

• Incidence of Three-Point Major Adverse Cardiovascular Events

  Up to 156 weeks

• Incidence of Heart Failure Events

  Up to 156 weeks

• Incidence of Peripheral Vascular Events

  Up to 156 weeks

• Change in CK-MB Level

  Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

• Change in Troponin-I Level

  Baseline, 12 weeks, 24 weeks, 52 weeks, 104 weeks, and 156 weeks

Study Arms (2)

Cilostazol

EXPERIMENTAL

Drug: Cilostazol

Aspirin

ACTIVE COMPARATOR

Drug: Aspirin

Interventions

Cilostazol DRUG

Drug: Cilostazol Other Name: Pletaal SR Capsule

Cilostazol

Aspirin DRUG

Drug: AspirinOther Name: ASA

Aspirin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Atherosclerosis

Interventions

Cilostazol; Aspirin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Soo Lim

CONTACT

82-10-9766-2706; limsoo@snu.ac.kr

Jiyoon Lee

CONTACT

82-10-4850-4828; rq857@snubh.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 22, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

KR (1)