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

Phase 4

Completed

• Conditions: Carotid Atherosclerosis; Type 2 Diabetes Mellitus
• Interventions: Drug: Aspirin; Drug: Cilostazol

• Registration Number: NCT03248401
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-26
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Primary Completion: 2018-10-21
• Study Completion: 2019-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin group	Aspirin	Aspirin 100 mg
Cilostazol group	Cilostazol	Cilostazol 200 mg or maximal tolerate dose

Primary Outcome Measures

Name	Time	Method
Change of carotid artery atherosclerosis	6 months	Plaque composition

Secondary Outcome Measures

Name	Time	Method
Change of carotid artery atherosclerosis 2	6 months	Changes in carotid artery stenosis after treatment
Change of carotid artery atherosclerosis 3	6 months	Plaque volume in carotid artery
Change of carotid artery atherosclerosis 1	6 months	Changes in carotid intima-media thickness after treatment

Trial Locations

Locations (1)

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