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

April 6, 2020 updated by: Soo Lim, Seoul National University Bundang Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cilostazol group
Cilostazol 200 mg or maximal tolerate dose
Drug: Cilostazol
Cilostazol 200 mg/day
Active Comparator: Aspirin group
Aspirin 100 mg
Drug: Aspirin
Aspirin 100 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of carotid artery atherosclerosis
Time Frame: 6 months
Plaque composition
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of carotid artery atherosclerosis 1
Time Frame: 6 months
Changes in carotid intima-media thickness after treatment
6 months
Change of carotid artery atherosclerosis 2
Time Frame: 6 months
Changes in carotid artery stenosis after treatment
6 months
Change of carotid artery atherosclerosis 3
Time Frame: 6 months
Plaque volume in carotid artery
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose metabolism 1
Time Frame: 6 months
HOMA-Insulin Resistance
6 months
Diabetic complication
Time Frame: 6 months
Albuminuria
6 months
Glucose metabolism 2
Time Frame: 6 months
HbA1c
6 months
Body composition
Time Frame: 6 months
Body fat mass and percent
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2016

Primary Completion (Actual)

October 21, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cilostazol_Carotid a. plaque

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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