Clopidogrel Versus Cilostazol on Vessels

NCT06402747 | Recruiting Phase 4 DMC

• 1 other identifier: B-2401-877-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Changes of carotid intima-media thickness

  mm

  52 weeks

Secondary Outcomes (9)

• Changes of circulation

  52 weeks

• Changes of HbA1c

  26 and 52 weeks

• Changes of glucose

  26 and 52 weeks

• Changes of body weight

  26 and 52 weeks

• Changes of whole body fat

  26 and 52 weeks

Study Arms (2)

Clopidogrel

EXPERIMENTAL

Clopidogrel 75mg once daily

Drug: Clopidogrel

Cilostazol

ACTIVE COMPARATOR

Cilostazol 200mg per day

Drug: Cilostazol

Interventions

Clopidogrel DRUG

Clopidogrel 75mg once daily

Also known as: Platless Tab.

Clopidogrel

Cilostazol DRUG

Cilostazol 200mg per day

Also known as: Cilostan CR Tab. 200mg

Cilostazol

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Samjin Pharmaceutical Co., Ltd.: collaborator

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

Clopidogrel; Cilostazol

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)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tetrazoles; Azoles; Quinolines

Study Officials

• Soo Lim, MD. Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Lim, MD. Ph.D.

CONTACT

+82317877035; limsoo@snu.ac.kr

Minji Sohn, Ph.D.

CONTACT

+82317878443; rainbowmjs@naver.com

Study Design

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

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 7, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)