Clopidogrel Versus Cilostazol on Vessels

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Bundang Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Individuals currently using antithrombotic or anticoagulant medications other than aspirin

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clopidogrel

    Drug

    Clopidogrel 75mg once daily

  • Cilostazol

    Drug

    Cilostazol 200mg per day

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: ClopidogrelExperimental treatment 1 intervention
Group B: CilostazolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes of carotid intima-media thickness

mm

Time frame
52 weeks

Secondary outcomes

1

Changes of circulation

measured by ankle brachial index and laser doppler

Time frame
52 weeks
2

Changes of HbA1c

%

Time frame
26 and 52 weeks
3

Changes of glucose

mg/dL

Time frame
26 and 52 weeks
4

Changes of body weight

kg

Time frame
26 and 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Bundang Hospital

Lead sponsor

Samjin Pharmaceutical Co., Ltd.

Collaborator