Clopidogrel Versus Cilostazol on Vessels

Seoul National University

Status and phase: Enrolling; Phase 4

Conditions: Type 2 Diabetes; Atherosclerosis

Treatments: Drug: Clopidogrel; Drug: Cilostazol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06402747

B-2401-877-002

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Clopidogrel

Experimental group

Description:

Clopidogrel 75mg once daily

Treatment:

Drug: Clopidogrel

Cilostazol

Active Comparator group

Description:

Cilostazol 200mg per day

Treatment:

Drug: Cilostazol