Clinical trial NCT06402747: Clopidogrel Versus Cilostazol on Vessels
Official title: Comparing Clopidogrel and Cilostazol in Type 2 Diabetes Patients With Carotid Atherosclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes
Atherosclerosis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Samjin Pharmaceutical Co., Ltd.
First posted: 2024-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Changes of carotid intima-media thickness
timeFrame: 52 weeks
Secondary outcomes:
measure: Changes of circulation
timeFrame: 52 weeks
measure: Changes of HbA1c
timeFrame: 26 and 52 weeks
measure: Changes of glucose
timeFrame: 26 and 52 weeks
measure: Changes of body weight
timeFrame: 26 and 52 weeks
measure: Changes of whole body fat
timeFrame: 26 and 52 weeks
measure: Changes of blood pressures
timeFrame: 26 and 52 weeks
measure: Changes of lipids
timeFrame: 26 and 52 weeks
measure: Changes of peripheral pain or ischemic symptoms
timeFrame: 26 and 52 weeks
measure: Changes of laboratory values related to blood clot
timeFrame: 26 and 52 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: