Clopidogrel Versus Cilostazol on Vessels
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clopidogrel, Cilostazol.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Atherosclerosis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing Clopidogrel and Cilostazol in Type 2 Diabetes Patients With Carotid Atherosclerosis
Overview
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.
Interventions
- Drug Clopidogrel
Clopidogrel 75mg once daily - Drug Cilostazol
Cilostazol 200mg per day
Primary outcome measures
- Changes of carotid intima-media thickness [Time frame: 52 weeks]
Secondary outcome measures (9)
- Changes of circulation [Time frame: 52 weeks]
- Changes of HbA1c [Time frame: 26 and 52 weeks]
- Changes of glucose [Time frame: 26 and 52 weeks]
- Changes of body weight [Time frame: 26 and 52 weeks]
- Changes of whole body fat [Time frame: 26 and 52 weeks]
- Changes of blood pressures [Time frame: 26 and 52 weeks]
- Changes of lipids [Time frame: 26 and 52 weeks]
- Changes of peripheral pain or ischemic symptoms [Time frame: 26 and 52 weeks]
- Changes of laboratory values related to blood clot [Time frame: 26 and 52 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Seoul National University Bundang Hospital — Seongnam-si
Identifiers
NCT: NCT06402747 · B-2401-877-002