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NCT Number: NCT06402747

Clopidogrel Versus Cilostazol on Vessels

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.

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Key information

Conditions

Type 2 Diabetes Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

clopidogrel

Drug

Clopidogrel 75mg once daily

Other names: Platless Tab.

Cilostazol

Drug

Cilostazol 200mg per day

Other names: Cilostan CR Tab. 200mg

Primary outcomes

  1. Changes of carotid intima-media thickness

    Time frame: 52 weeks

    mm

Secondary outcomes

  1. Changes of circulation

    Time frame: 52 weeks

    measured by ankle brachial index and laser doppler

  2. Changes of HbA1c

    Time frame: 26 and 52 weeks

    %

  3. Changes of glucose

    Time frame: 26 and 52 weeks

    mg/dL

  4. Changes of body weight

    Time frame: 26 and 52 weeks

    kg

  5. Changes of whole body fat

    Time frame: 26 and 52 weeks

    measured by bioelectrical impedance analysis

  6. Changes of blood pressures

    Time frame: 26 and 52 weeks

    systolic, diastolic (mmHg)

  7. Changes of lipids

    Time frame: 26 and 52 weeks

    total cholesterol, triglycerides, LDLc, HDLc (mg/dL)

  8. Changes of peripheral pain or ischemic symptoms

    Time frame: 26 and 52 weeks

    measured by questionnaires (visual analogue scale: 100)

  9. Changes of laboratory values related to blood clot

    Time frame: 26 and 52 weeks

    prothrombin time, activated partial thromboplastin time

Study contacts

Contact information is provided by the study sponsor or research team.

Minji Sohn, Ph.D.

CONTACT

[email protected]

+82317878443

Soo Lim, MD. Ph.D.

CONTACT

[email protected]

+82317877035

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Samjin Pharmaceutical Co., Ltd.

Registry information

Official study title

Comparing Clopidogrel and Cilostazol in Type 2 Diabetes Patients With Carotid Atherosclerosis

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 7, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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