Clopidogrel Versus Cilostazol on Vessels

NCT ID: NCT06402747

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-16

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Clopidogrel

Clopidogrel 75mg once daily

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Clopidogrel 75mg once daily

Cilostazol

Cilostazol 200mg per day

Group Type ACTIVE_COMPARATOR

Cilostazol

Intervention Type DRUG

Cilostazol 200mg per day

Interventions

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Clopidogrel

Clopidogrel 75mg once daily

Intervention Type DRUG

Cilostazol

Cilostazol 200mg per day

Intervention Type DRUG

Other Intervention Names

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Platless Tab. Cilostan CR Tab. 200mg

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samjin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo Lim, MD. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Soo Lim, MD. Ph.D.

Role: CONTACT

+82317877035

Minji Sohn, Ph.D.

Role: CONTACT

+82317878443

Facility Contacts

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Soo Lim

Role: primary

+82317877035 ext. 82317877035

Minji Sohn

Role: backup

+82317878443 ext. 82317878443

Other Identifiers

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B-2401-877-002

Identifier Type: -

Identifier Source: org_study_id

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