Clopidogrel Versus Cilostazol on Vessels

Phase 4

Recruiting

• Conditions: Type 2 Diabetes; Atherosclerosis
• Interventions: Drug: Clopidogrel; Drug: Cilostazol

• Registration Number: NCT06402747
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-16
• Study First Submitted: 2024-04-26
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-07
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel	Clopidogrel	Clopidogrel 75mg once daily
Cilostazol	Cilostazol	Cilostazol 200mg per day

Primary Outcome Measures

Name	Time	Method
Changes of carotid intima-media thickness	52 weeks	mm

Secondary Outcome Measures

Name	Time	Method
Changes of glucose	26 and 52 weeks	mg/dL
Changes of blood pressures	26 and 52 weeks	systolic, diastolic (mmHg)
Changes of peripheral pain or ischemic symptoms	26 and 52 weeks	measured by questionnaires (visual analogue scale: 100)
Changes of laboratory values related to blood clot	26 and 52 weeks	prothrombin time, activated partial thromboplastin time
Changes of circulation	52 weeks	measured by ankle brachial index and laser doppler
Changes of HbA1c	26 and 52 weeks
Changes of body weight	26 and 52 weeks	kg
Changes of whole body fat	26 and 52 weeks	measured by bioelectrical impedance analysis
Changes of lipids	26 and 52 weeks	total cholesterol, triglycerides, LDLc, HDLc (mg/dL)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of