Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes

Seoul National University Bundang Hospital50 enrolled

Overview

To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus Carotid Atherosclerosis

Interventions

CilostazolDRUG

Cilostazol 200 mg/day

AspirinDRUG

Aspirin 100 mg/day

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 30 and 80 years * Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%) * Carotid plaque on 3D ultrasound Exclusion Criteria: * Acute bleeding or bleeding tendency * Diagnosed with heart failure * Suggestive of ischemia on ECG * Uncontrolled hypertension * Recently diagnosed with peptic ulcer disease * Taking other antiplatelet agents * Hypersensitivity to salicylic acid * Aspirin induced asthma * Severe kidney, liver, heart disease

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Change of carotid artery atherosclerosis

Plaque composition

Time frame: 6 months

Secondary Outcomes

Change of carotid artery atherosclerosis 1

Changes in carotid intima-media thickness after treatment

Time frame: 6 months

Change of carotid artery atherosclerosis 2

Changes in carotid artery stenosis after treatment

Time frame: 6 months

Change of carotid artery atherosclerosis 3

Plaque volume in carotid artery

Time frame: 6 months

Data from ClinicalTrials.gov

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