Clopidogrel Versus Cilostazol on Vessels

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06402747
• Other study ID #: B-2401-877-002
• Status: Recruiting
• Phase: Phase 4
• Start date: April 16, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Seoul National University Bundang Hospital
• Contact: Soo Lim, MD. Ph.D.
• Phone: +82317877035
• Email: limsoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Clopidogrel
Clopidogrel 75mg once daily
• Cilostazol
Cilostazol 200mg per day

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Samjin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of carotid intima-media thickness	mm	52 weeks
Secondary	Changes of circulation	measured by ankle brachial index and laser doppler	52 weeks
Secondary	Changes of HbA1c		26 and 52 weeks
Secondary	Changes of glucose	mg/dL	26 and 52 weeks
Secondary	Changes of body weight	kg	26 and 52 weeks
Secondary	Changes of whole body fat	measured by bioelectrical impedance analysis	26 and 52 weeks
Secondary	Changes of blood pressures	systolic, diastolic (mmHg)	26 and 52 weeks
Secondary	Changes of lipids	total cholesterol, triglycerides, LDLc, HDLc (mg/dL)	26 and 52 weeks
Secondary	Changes of peripheral pain or ischemic symptoms	measured by questionnaires (visual analogue scale: 100)	26 and 52 weeks
Secondary	Changes of laboratory values related to blood clot	prothrombin time, activated partial thromboplastin time	26 and 52 weeks